System, Test, Blood Glucose, Over The Counter
FDA product code NBW · Class II (moderate risk) · 21 CFR 862.1345 · Clinical Chemistry
510510(k) clearances
0PMA approvals
101recalls
Manufacturers
- Taidoc Technology Corporation 65
- I-Sens, Inc. 21
- Roche Diagnostics Corp. 19
- Abbott Diabetes Care, Inc. 19
- Bionime Corporation 18
- Apex BioTechnology Corp. 18
- Infopia Co, Ltd. 15
- Eps Bio Technology Corp. 14
- Agamatrix 14
- Bayer Healthcare, LLC 13
- ACON Laboratories, Inc. 13
- Tyson Bioresearch, Inc. 13
- Lifescan, Inc. 13
- Abbott Laboratories 12
- Biotest Medical Corp. 10
- Home Diagnostics, Inc. 10
- Ok Biotech Co., Ltd. 9
- Hmd Biomedical, Inc. 8
- Andon Health Co, Ltd. 8
- Andon Medical Co., Ltd. 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 01/19/2024SE |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring SystemNBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 12/22/2023SE |
| K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring SystemNBW · Traditional | Sinocare, Inc. | 12/01/2023SE |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 08/10/2023SE |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemNBW · Traditional | Roche Diabetes Care GmbH | 08/10/2023SE |
| K223722 | MIO Blood Glucose Monitoring SystemNBW · Traditional | Mio Labs, Inc. | 06/28/2023SE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 12/21/2022SE |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW · Special | Ascensia Diabetes Care U.S., Inc. | 11/18/2022SE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 11/04/2022SE |
| K213061 | SuperCheck Pro Blood Glucose Monitoring SystemNBW · Traditional | Ok Biotech Co., Ltd. | 10/07/2022SE |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring SystemNBW · Special | Hmd Biomedical, Inc. | 08/29/2022SE |
| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | Apex BioTechnology Corp. | 08/25/2022SE |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose…NBW · Special | Bioland Technology, Ltd. | 08/12/2022SE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional | Taidoc Technology Corporation | 06/16/2022SE |
| K203711 | IWL2020 Blood Glucose Monitoring SystemNBW · Traditional | Roche Diabetes Care, Inc. | 05/06/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | Apex BioTechnology Corp. | 04/06/2022SE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 03/29/2022SE |
| K193406 | CardioChek Plus Test System; CardioChek Plus Home Test SystemNBW · Traditional | Polymer Technology Systems, Inc. D/B/A Pts… | 02/26/2022SE |
| K193407 | Contour® next GEN Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 12/23/2021SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | Apex BioTechnology Corp. | 10/15/2021SE |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose…NBW · Special | I-Sens, Inc. | 10/05/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 09/15/2021SE |
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose SystemNBW · Special | Eps Bio Technology Corp. | 09/01/2021SE |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW · Special | Ascensia Diabetes Care | 08/11/2021SE |
| K203562 | Finetest Lite Blood Glucose Monitoring SystemNBW · Special | Osang Healthcare Co. , Ltd. | 07/13/2021SE |
| K201396 | Finetest Lite Smart Blood Glucose Monitoring SystemNBW · Special | Osang Healthcare Co. , Ltd. | 10/16/2020SE |
| K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring SystemNBW · Traditional | Microtech Medical, Inc. | 09/11/2020SE |
| K200277 | Livongo Blood Glucose Monitoring System (BG1000)NBW · Traditional | Livongo Health, Inc. | 06/04/2020SE |
| K191657 | Bioland Blood Glucose Monitoring SystemNBW · Traditional | Bioland Technology, Ltd. | 03/20/2020SE |
| K193475 | OneTouch Verio Reflect Blood Glucose Monitoring SystemNBW · Traditional | Lifescan Europe GmbH | 02/14/2020SE |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 01/24/2020SE |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 01/17/2020SE |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 12/13/2019SE |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…NBW · Special | Ascensia Diabetes Care | 11/08/2019SE |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose SystemNBW · Special | Eps Bio Technology Corp. | 11/01/2019SE |
| K192175 | On Call Express II Blood Glucose Monitoring SystemNBW · Special | ACON Laboratories, Inc. | 10/17/2019SE |
| K191038 | On Call Express Voice Blood Glucose Monitoring SystemNBW · Special | ACON Laboratories, Inc. | 06/12/2019SE |
| K190579 | TD-4183 Blood Glucose Monitoring SystemNBW · Traditional | Taidoc Technology Corporation | 06/04/2019SE |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…NBW · Traditional | Bionime Corporation | 06/02/2019SE |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring SystemNBW · Traditional | Hmd Biomedical, Inc. | 05/08/2019SE |
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring SystemNBW · Special | Arkray Factory, Inc. | 04/10/2019SE |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)NBW · Traditional | Andon Health Co, Ltd. | 02/01/2019SE |
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…NBW · Traditional | Vivachek Laboratories, Inc. | 12/19/2018SE |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW · Special | Roche Diabetes Care | 12/13/2018SE |
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…NBW · Special | Tyson Bioresearch, Inc. | 11/30/2018SE |
| K181588 | POPS! one Blood Glucose Monitoring SystemNBW · Traditional | Taidoc Technology Corporation | 11/30/2018SE |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…NBW · Special | Tyson Bioresearch, Inc. | 11/29/2018SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 11/28/2018SE |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…NBW · Special | I-Sens, Inc. | 11/01/2018SE |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring…NBW · Traditional | ACON Laboratories, Inc. | 10/03/2018SE |
| K182286 | Oh'Care Lite Smart Blood Glucose Monitoring SystemNBW · Special | Osang Healthcare Co. , Ltd. | 09/19/2018SE |
| K180866 | CareSens S Fit Blood Glucose Monitoring SystemNBW · Traditional | I-Sens, Inc. | 08/31/2018SE |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose SystemNBW · Special | Eps Bio Technology Corp. | 08/24/2018SE |
| K173658 | Confidence Blood Glucose Monitoring SystemNBW · Traditional | Applied Biomedical, LLC | 08/21/2018SE |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…NBW · Traditional | Bionime Corporation | 08/17/2018SE |
| K173505 | FORA GTel Blood Glucose Monitoring SystemNBW · Traditional | Foracare, Inc. | 08/09/2018SE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special | Taidoc Technology Corporation | 07/12/2018SE |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System…NBW · Traditional | Bionime Corporation | 06/19/2018SE |
| K181316 | POGO Automatic Blood Glucose Monitoring SystemNBW · Special | Intuity Medical, Inc. | 06/14/2018SE |
| K172723 | Dario LC Blood Glucose Monitoring SystemNBW · Traditional | Labstyle Innovation, Ltd. | 03/23/2018SE |
| K180196 | On Call Express Mobile Blood Glucose Monitoring SystemNBW · Special | ACON Laboratories, Inc. | 03/07/2018SE |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 12/13/2017SE |
| K170464 | StatStrip Xpress Blood Glucose Monitoring SystemNBW · Traditional | Nova Biomedical Corporation | 11/07/2017SE |
| K163087 | PixoTest Blood Glucose Monitoring SystemNBW · Traditional | Ixensor Company , Ltd. | 11/02/2017SE |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…NBW · Special | I-Sens, Inc. | 10/19/2017SE |
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…NBW · Traditional | Sd Biosensor | 10/17/2017SE |
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring…NBW · Traditional | All Medicus Co., Ltd. | 10/13/2017SE |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…NBW · Traditional | Tyson Bioresearch, Inc. | 10/06/2017SE |
| K170264 | Gold AQ Blood Glucose Monitoring SystemNBW · Traditional | Changsha Sinocare, Inc. | 10/05/2017SE |
| K171941 | FreeStyle Precision Neo Blood Glucose Test StripsNBW · Traditional | Abbott Diabetes Care, Inc. | 09/27/2017SE |
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)NBW · Special | Biotest Medical Corporation | 09/20/2017SE |
| K171785 | WowGoHealth Blood Glucose Monitoring SystemNBW · Special | Biotest Medical Corporation | 09/15/2017SE |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…NBW · Traditional | Andon Health Co, Ltd. | 09/15/2017SE |
| K170064 | GLUCOCARD W Blood Glucose Monitoring SystemNBW · Traditional | Arkray Factory, Inc. | 08/16/2017SE |
| K163159 | Dario Blood Glucose Monitoring SystemNBW · Traditional | Labstyle Innovations, Ltd. | 07/19/2017SE |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…NBW · Traditional | Bionime Corporation | 07/06/2017SE |
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…NBW · Traditional | Tianjin Empecs Medical Device Co., Ltd. | 06/07/2017SE |
| K161790 | iGlucose Blood Glucose Monitoring SystemNBW · Traditional | Bionime Corporation | 05/02/2017SE |
| K160179 | VivaChek Ino Blood Glucose Monitoring SystemNBW · Traditional | Vivachek Laboratories, Inc. | 04/21/2017SE |
| K162382 | Smart Dongle Blood Glucose Monitoring SystemNBW · Traditional | Taidoc Technology Corporation | 04/14/2017SE |
| K162203 | POGO Automatic Blood Glucose Monitoring SystemNBW · Traditional | Intuity Medical, Inc. | 04/06/2017SE |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…NBW · Special | Tianjin Empecs Medical Device Co., Ltd. | 03/21/2017SE |
| K170267 | BGM009 Plus Blood Glucose Monitoring SystemNBW · Special | Apex BioTechnology Corp. | 03/09/2017SE |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemNBW · Traditional | Andon Health Co, Ltd. | 02/16/2017SE |
| K162430 | UniStrip1 Generic Blood Glucose Test StripsNBW · Traditional | Ok Biotech Co., Ltd. | 01/19/2017SE |
| K162336 | Contour Next EZ Blood Glucose Monitoring SystemNBW · Special | Ascensia Diabetes Care U.S., Inc. | 01/12/2017SE |
| K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemNBW · Traditional | Apex BioTechnology Corp. | 12/23/2016SE |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring SystemNBW · Traditional | I-Sens, Inc. | 12/16/2016SE |
| K161834 | One Drop Blood Glucose Monitoring SystemNBW · Special | Agamatrix, Inc. | 11/30/2016SE |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 11/17/2016SE |
| K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…NBW · Traditional | Taidoc Technology Corporation | 11/10/2016SE |
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose…NBW · Special | Infopia Co, Ltd. | 09/28/2016SE |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW · Traditional | Roche Diabetes Care, Inc. | 08/31/2016SE |
| K153286 | iHealth Align Gluco-Monitoring systemNBW · Traditional | Andon Health Co, Ltd. | 08/19/2016SE |
| K153278 | Wireless Smart Gluco-Monitoring SystemNBW · Traditional | Andon Health Co, Ltd. | 08/19/2016SE |
| K161867 | On Call Pro Blood Glucose Monitoring SystemNBW · Special | Acon Laboratories | 08/05/2016SE |
| K160038 | UniStrip1 Generic Blood Glucose Test StripsNBW · Traditional | Ok Biotech Co., Ltd. | 07/29/2016SE |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose…NBW · Traditional | Ok Biotech Co., Ltd. | 07/20/2016SE |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…NBW · Special | Ascensia Diabetes Care U.S., Inc. | 06/24/2016SE |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…NBW · Special | Sd Biosensor | 06/24/2016SE |
| K160156 | StatStrip Xpress Blood Glucose Monitoring SystemNBW · Traditional | Nova Biomedical Corporation | 06/23/2016SE |
| K152493 | POGO Automatic Blood Glucose Monitoring SystemNBW · Traditional | Intuity Medical, Inc. | 04/25/2016SE |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemNBW · Traditional | Agamatrix, Inc. | 04/21/2016SE |
| K143548 | TRUE METRIX GO Self Monitoring Blood Glucose SystemNBW · Traditional | Trividia Health, Inc. | 04/01/2016SE |
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring SystemNBW · Traditional | Abbott Diabetes Care, Inc. | 02/19/2016SE |
| K143169 | MyGlucoHealth Wireless SystemNBW · Special | Entra Health Systems | 01/08/2016SE |
| K150817 | Dario Blood Glucose Monitoring SystemNBW · Traditional | Labstyle Innovations, Ltd. | 12/21/2015SE |
| K152442 | Freestyle Freedom Blood Glucose Monitoring SytemNBW · Special | Abbott Laboratories | 12/17/2015SE |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring SystemNBW · Traditional | Ok Biotech Co., Ltd. | 12/17/2015SE |
| K151611 | OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemNBW · Traditional | Lifescan Europe | 12/14/2015SE |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring…NBW · Traditional | Andon Health Co, Ltd. | 12/04/2015SE |
| K151658 | Gmate Origin Blood Glucose Monitoring SystemNBW · Traditional | Philosys, Inc. | 12/01/2015SE |
| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | Bayer Healthcare | 11/25/2015SE |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…NBW · Traditional | Sd Biosensor | 11/24/2015SE |
| K150299 | Gmate SMART Blood Glucose Monitoring SystemNBW · Traditional | Philosys, Inc. | 11/19/2015SE |
| K150396 | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose…NBW · Special | Apex BioTechnology Corp. | 10/14/2015SE |
| K140325 | Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring SystemNBW · Traditional | Joinsoon Medical Technology Co, Ltd. | 10/13/2015SE |
| K141656 | Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring SystemNBW · Traditional | Philosys, Inc. | 10/02/2015SE |
| K142928 | FreeStyle Precision Neo Blood Glucose Monitoring SystemNBW · Special | Abbott Diabetes Care, Inc. | 09/30/2015SE |
| K151100 | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose…NBW · Special | Taidoc Technology Corporation | 09/29/2015SE |
| K151595 | On Call Express Pro Blood Glucose Monitoring SystemNBW · Traditional | ACON Laboratories, Inc. | 09/05/2015SE |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose…NBW · Special | Infopia Co, Ltd. | 08/26/2015SE |
| K151164 | Assure Prism multi Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 08/07/2015SE |
| K132929 | SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…NBW · Traditional | Sd Biosensor, Inc. | 08/05/2015SE |
| K150214 | OneTouch Verio Flex Blood Glucose Monitoring SystemNBW · Traditional | Lifescan Europe | 07/31/2015SE |
| K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System…NBW · Traditional | Bionime Coporation | 06/09/2015SE |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring SystemNBW · Special | Abbott Laboratories | 06/05/2015SE |
| K150332 | FreeStyle Lite Blood Glucose Monitoring SystemNBW · Special | Abbott Laboratories | 06/05/2015SE |
| K143387 | GE333 Blood Glucose Monitoring SystemNBW · Traditional | Bionime Coporation | 06/03/2015SE |
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemNBW · Special | Polymer Technology Systems, Inc. | 05/22/2015SE |
| K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…NBW · Traditional | Biotest Medical Corp. | 05/19/2015SE |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose…NBW · Special | Hmd Biomedical, Inc. | 05/14/2015SE |
| K143467 | FORA GD43 Blood Glucose Monitoring SystemNBW · Traditional | Taidoc Technology Corporation | 05/07/2015SE |
| K141036 | BGM009 Blood Glucose Monitoring SystemNBW · Traditional | Apex BioTechnology Corp. | 05/01/2015SE |
| K132663 | I-Qare Ds-W Blood Glucose Monitoring SystemNBW · Traditional | Alliance International Co., Ltd. | 04/20/2015SE |
| K141914 | Prodigy Autocode Eject Blood Glucose Monitoring SystemNBW · Traditional | Ok Biotech Co., Ltd. | 04/15/2015SE |
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional…NBW · Special | Nipro Diagnostics, Inc. | 03/26/2015SE |
| K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring SystemNBW · Special | Roche Diagnostics | 03/03/2015SE |
| K141862 | HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableNBW · Traditional | H2, Inc. | 12/02/2014SE |
| K140371 | Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test…NBW · Traditional | Abbott Diabetes Care, Inc. | 09/30/2014SE |
| K141829 | Glucovitaal H1A Blood Glucose Monitoring SystemNBW · Special | Ceragem Medisys, Inc. | 09/24/2014SE |
| K131173 | FIA Blood Glucose Monitoring System (G2)NBW · Traditional | Hmd Biomedical, Inc. | 09/18/2014SE |
| K142035 | Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring…NBW · Traditional | Arkray Factory, Inc. | 09/05/2014SE |
| K133741 | ACCU-CHEK Performa Blood Glucose Monitoring SystemNBW · Traditional | Roche Diagnostics | 08/29/2014SE |
| K140210 | Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720NBW · Traditional | Bionime Corporation | 08/22/2014SE |
| K132633 | Okmeter Direct Blood Glucose Monitoring SystemNBW · Traditional | Ok Biotech Co., Ltd. | 08/14/2014SE |
| K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationNBW · Traditional | Philosys, Inc. | 08/04/2014SE |
| K140100 | True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional…NBW · Traditional | Nipro Diagnostics, Inc. | 08/01/2014SE |
| K140141 | Labonacheck Gluppy Blood Glucose Monitoring SystemNBW · Special | Ceragem Medisys, Inc. | 07/03/2014SE |
| K133260 | Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemNBW · Traditional | Tianjin Empecs Medical Device Co., Ltd. | 06/27/2014SE |
| K132180 | Ideal Life Gluco-Manager Blood Glucose Monitoring SystemNBW · Traditional | Ideal Life, Inc. | 06/25/2014SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | Bayer Healthcare, LLC | 06/23/2014SE |
| K133790 | Ihealth Align Mini Gluco-Monitoring SystemNBW · Special | Andon Health Co, Ltd. | 05/22/2014SE |
| K133862 | Accu-Chek Aviva Plus SystemNBW · Special | Roche Diagnostics Corporation | 04/29/2014SE |
| K132406 | Elementv Blood Glucose Monitoring SystemNBW · Traditional | Infopia Co, Ltd. | 04/18/2014SE |
| K133522 | Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),RIGHTEST…NBW · Traditional | Bionime Coporation | 04/17/2014SE |
| K133389 | EM40 Self-Monitoring Blood Glucose SystemNBW · Special | Eps Bio Technology Corp. | 04/15/2014SE |
| K133045 | Element TM Lite Blood Glucose Monitoring SystemNBW · Traditional | Infopia Co, Ltd. | 04/10/2014SE |
| K133647 | EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose SystemNBW · Special | Eps Bio Technology Corp. | 02/27/2014SE |
| K133509 | Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring…NBW · Special | Biotest Medical Corp. | 02/21/2014SE |
| K123517 | Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…NBW · Special | Sd Biosensor | 01/17/2014SE |
| K131469 | Acon on Call Diabetes Management SoftwareNBW · Special | ACON Laboratories, Inc. | 01/06/2014SE |
| K132511 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemNBW · Special | Abbott Diabetes Care, Inc. | 12/24/2013SE |
| K130284 | On Call Sharp Blood Glucose Monitoring SystemNBW · Traditional | ACON Laboratories, Inc. | 12/20/2013SE |
| K133346 | Smartlog Diabetes Management SoftwareNBW · Special | I-Sens, Inc. | 12/19/2013SE |
| K132086 | On Call Express Blood Glucose Monitoring SystemNBW · Traditional | ACON Laboratories, Inc. | 12/19/2013SE |
| K132862 | Healthpro Professional Blood Glucose Monitoring SystemNBW · Special | Infopia Co, Ltd. | 12/12/2013SE |
| K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…NBW · Traditional | Infopia Co, Ltd. | 12/05/2013SE |
| K122340 | Prodigy ChoiceNBW · Traditional | Prodigy Diabetes Care, LLC | 11/26/2013SE |
| K132288 | Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood…NBW · Special | I-Sens, Inc. | 11/22/2013SE |
| K123090 | GLB Benecheck Premium Glu Monitoring SystemNBW · Traditional | General Life Biotechnology Co., Ltd. | 11/22/2013SE |
| K132821 | Agamatrix Health ManagerNBW · Special | Agamatrix, Inc. | 11/20/2013SE |
| K113135 | Unistrip 1NBW · Traditional | Unistrip Technologies, LLC | 11/06/2013SE |
| K122338 | Preferred Blood Glucose Monitoring SystemNBW · Traditional | Prodigy Diabetes Care, LLC | 11/05/2013SE |
| K132338 | DA01 Blood Glucose Monitoring SystemNBW · Special | Delbio Incorporation | 10/24/2013SE |
| K132272 | Glooko Device System for Glooko ApplicationNBW · Special | Glooko, Inc. | 10/17/2013SE |
| K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNBW · Traditional | Nova Biomedical Corporation | 10/17/2013SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | Bayer Healthcare | 09/26/2013SE |
| K131363 | Onetouch Verio Blood Glucose Monitoring SystemNBW · Traditional | Cilag GmbH International | 08/30/2013SE |
| K130244 | Diatrue Plus Blood Glucose Monitoring SystemNBW · Traditional | Delbio Incorporation | 08/23/2013SE |
| K130696 | Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose…NBW · Traditional | I-Sens, Inc. | 08/21/2013SE |
| K132072 | True Metrix Self-Monitoring Blood Glucose System, True Metri Pro Professional Monitoring…NBW · Special | Nipro Diagnostics, Inc. | 08/15/2013SE |
| K122181 | Ebchek Blood Glucose Monitoring SystemNBW · Traditional | Visgeneer, Inc. | 08/15/2013SE |
| K131419 | Acura Plus Multi Blood Glucose Monitoring SystemNBW · Special | I-Sens, Inc. | 08/09/2013SE |
| K131029 | Accu-Chek Aviva Plus Test StripNBW · Special | Roche Diagnostics Operations, Inc. | 08/09/2013SE |
| K130181 | Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring SystemNBW · Traditional | Infopia Co, Ltd. | 07/31/2013SE |
| K130621 | Broadmaster Healthcare SystemNBW · Traditional | Broadmaster Biotech Corporation | 07/30/2013SE |
| K130657 | Linkdr 2.0 Diabetes Management SoftwareNBW · Traditional | All Medicus Co., Ltd. | 07/15/2013SE |
| K123559 | Solusmobile Blood Glucose Managment SystemNBW · Traditional | Biotest Medical Corp. | 06/28/2013SE |
| K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemNBW · Traditional | Abbott Diabetes Care | 06/27/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1548-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1547-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1546-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1545-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-0413-2026 Class II | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog…Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result… | Trividia Health, Inc. | 10/07/2025Open, Classified |
| Z-1270-2025 Class II | Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips… | Telcare, LLC | 01/30/2025Open, Classified |
| Z-2174-2024 Class II | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary…The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and… | Roche Diabetes Care, Inc. | 05/13/2024Open, Classified |
| Z-2211-2023 Class II | Contour next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number… | Ascensia Diabetes Care US, Inc. | 05/19/2023Open, Classified |
| Z-1461-2022 Class II | etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.Device was marketed without FDA 510(k) clearance or a PMA. | Touch US Llc | 06/21/2022Open, Classified |
| Z-2354-2021 Class II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test… | Roche Diabetes Care, Inc. | 07/28/2021Open, Classified |
| Z-1942-2021 Class II | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | Cardinal Health Inc. | 03/16/2021Open, Classified |
| Z-1938-2021 Class II | ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | Cardinal Health Inc. | 03/16/2021Open, Classified |
| Z-1936-2021 Class II | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | Cardinal Health Inc. | 03/16/2021Open, Classified |
| Z-2201-2020 Class II | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the…One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX… | Trividia Health, Inc. | 04/20/2020Terminated |
| Z-0999-2020 Class II | ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog…Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a… | Roche Diabetes Care, Inc. | 12/11/2019Terminated |
| Z-0998-2020 Class II | Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System…Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a… | Roche Diabetes Care, Inc. | 12/11/2019Terminated |
| Z-0997-2020 Class II | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System…Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a… | Roche Diabetes Care, Inc. | 12/11/2019Terminated |
| Z-0835-2020 Class II | Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | Polymer Technology Systems, Inc. | 12/02/2019Terminated |
| Z-0834-2020 Class II | Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | Polymer Technology Systems, Inc. | 12/02/2019Terminated |
| Z-0833-2020 Class II | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | Polymer Technology Systems, Inc. | 12/02/2019Terminated |
| Z-0832-2020 Class II | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | Polymer Technology Systems, Inc. | 12/02/2019Terminated |
| Z-1557-2020 Class II | Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters… | Abbott Diabetes Care, Inc. | 11/14/2019Terminated |
| Z-1556-2020 Class II | Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023…Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters… | Abbott Diabetes Care, Inc. | 11/14/2019Terminated |
| Z-0752-2020 Class II | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0751-2020 Class II | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0750-2020 Class II | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0749-2020 Class II | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0748-2020 Class II | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0747-2020 Class II | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT…Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Roche Diabetes Care, Inc. | 09/30/2019Terminated |
| Z-0260-2020 Class II | Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software…The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood… | Labstyle Innovations | 08/29/2019Terminated |
| Z-2357-2019 Class II | Microdot Xtra blood glucose test stripsThe firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with… | Cambridge Sensors Limited | 07/26/2018Open, Classified |
| Z-1543-2018 Class II | PTS Panels CHOL+GLU Test Strips (REF 1765)Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life… | Polymer Technology Systems, Inc. | 03/14/2018Terminated |
| Z-2766-2019 Class II | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose…Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or… | Roche Diabetes Care, Inc. | 06/12/2017Terminated |
| Z-2765-2019 Class II | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose…Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or… | Roche Diabetes Care, Inc. | 06/12/2017Terminated |
| Z-2883-2016 Class II | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Product gives incorrect low blood glucose levels. | Trividia Health | 06/28/2016Open, Classified |
| Z-2882-2016 Class II | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Product gives incorrect low blood glucose levels. | Trividia Health | 06/28/2016Open, Classified |
| Z-2881-2016 Class II | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Product gives incorrect low blood glucose levels. | Trividia Health | 06/28/2016Open, Classified |
| Z-2880-2016 Class II | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and…Product gives incorrect low blood glucose levels. | Trividia Health | 06/28/2016Open, Classified |
| Z-0741-2020 Class II | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or…This lot of test strips is showing an under-recovery when tested against a reference method. | Polymer Technology Systems, Inc. | 03/15/2016Terminated |
| Z-1587-2016 Class II | The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an…The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch… | Livongo Health | 02/18/2016Terminated |
| Z-0855-2015 Class II | UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for…Failure to submit a 510(k) for device labeling changes. | Unistrip Technologies LLC | 11/20/2014Terminated |
| Z-1616-2014 Class II | ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count…Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low… | Roche Diagnostics Operations, Inc. | 04/14/2014Terminated |
| Z-1212-2014 Class I | FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by…Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage… | Abbott Diabetes Care, Inc. | 02/19/2014Terminated |
| Z-1211-2014 Class I | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room…Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage… | Abbott Diabetes Care, Inc. | 02/19/2014Terminated |
| Z-0486-2014 Class I | FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100…Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose… | Abbott Diabetes Care, Inc. | 11/18/2013Terminated |
| Z-0485-2014 Class I | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6…Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose… | Abbott Diabetes Care, Inc. | 11/18/2013Terminated |
| Z-0385-2014 Class II | ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo…There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual… | Roche Diagnostics Operations, Inc. | 10/25/2013Terminated |
| Z-0910-2014 Class II | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for…Manufactured with an incorrect factory set unit of measure. | Nipro Diagnostics, Inc. | 10/02/2013Terminated |
| Z-0909-2014 Class II | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for…Manufactured with an incorrect factory set unit of measure. | Nipro Diagnostics, Inc. | 10/02/2013Terminated |
| Z-1906-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507…Reports of false abnormally high glucose readings from test strips | Nova Biomedical Corporation | 07/15/2013Terminated |