Continuous Measurement Thermometer
FDA product code FLL · Class II (moderate risk) · 21 CFR 880.2910 · General Hospital
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
798510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Microlife Intellectual Property GmbH 20
- R & D Batteries, Inc. 19
- Taidoc Technology Corporation 16
- Radiant Innovation, Inc. 15
- K-Jump Health Co., Ltd. 14
- Mesure Technology Co., Ltd. 13
- Avita Corporation 11
- Mon-A-Therm, Inc. 11
- Respiratory Support Products, Inc. 10
- Electromedics, Inc. 10
- Yellow Springs Instrument Co., Inc. 10
- Hangzhou Hua'An Medical & Health Instruments Co., 8
- Y 8
- Actherm, Inc. 8
- Joytech Healthcare Co. , Ltd. 7
- Mallinckrodt Critical Care 7
- Alicn Medical Shenzhen, Inc. 7
- Medisim, Ltd. 7
- Kaz USA, Inc., A Helen of Troy Company 7
- Oriental System Technology, Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | Unimed Medical Supplies, Inc. | 06/05/2026SE |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 01/08/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 06/23/2025SE |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional | Shenzhen Medke Technology Co., Ltd. | 06/20/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 05/22/2025SE |
| K243082 | Infrared ThermometerFLL · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 04/25/2025SE |
| K250401 | AION TempShieldFLL · Traditional | Aion Biosystems, Inc. | 03/14/2025SE |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional | Shenzhen Finicare Co., Ltd. | 02/14/2025SE |
| K240333 | Wearable Digital Thermometer (T31)FLL · Traditional | Guangdong Genial Technology Co., Ltd. | 10/30/2024SE |
| K240223 | FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional | Metko Medikal VE Tibbi Cihazlar Dis Ticaret… | 10/25/2024SE |
| K240220 | Aulisa Temperature Module (TM0002)FLL · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 09/27/2024SE |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)FLL · Traditional | Covidien | 08/20/2024SE |
| K233280 | SteadyTempFLL · Traditional | Steadysense GmbH | 06/21/2024SE |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)FLL · Traditional | Radiant Innovation, Inc. | 06/05/2024SE |
| K240109 | Medical electronic thermometer (FC01, FC02)FLL · Traditional | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 04/12/2024SE |
| K233192 | Wireless Smart ThermometerFLL · Traditional | Famidoc Technology Company Limited | 04/05/2024SE |
| K230889 | Digital ThermometerFLL · Traditional | Wenzhou Yosun Medical Technology Co.,Ltd | 04/03/2024SE |
| K240023 | Probe Covers (YF-001, YF-002)FLL · Traditional | Shenzhen YI Fang Blister Packaging Co., Ltd. | 03/01/2024SE |
| K232473 | Infrared Thermometer: Model YJ600FLL · Traditional | Zhuhai Yueja Medical Device Technology Co., Ltd. | 02/09/2024SE |
| K231625 | VitalDetectFLL · Traditional | Wellvii, Inc. | 02/02/2024SE |
| K232678 | Digital Thermometer, Model T28, T28LFLL · Traditional | Guangdong Genial Technology Co., Ltd. | 01/31/2024SE |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345…FLL · Traditional | Alicn Medical Shenzhen, Inc. | 12/22/2023SE |
| K222057 | ThermoclickFLL · Traditional | T&R BIOFAB CO., Ltd. | 12/05/2023SE |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 10/14/2023SE |
| K223807 | Reusable Temperature Probe, Disposable Temperature ProbeFLL · Traditional | Shenzhen Sino-K Medical Technology Co.,Ltd | 08/25/2023SE |
| K230298 | Celsi MonitorFLL · Traditional | Hadleigh Health Technologies | 08/16/2023SE |
| K232010 | iTEMPSHIELDFLL · Traditional | Aion Biosystems, Inc. | 08/04/2023SE |
| K223037 | Infrared Thermometer, Model: IR8807FLL · Traditional | Shen Zhen Rong Feng Technology Co., Ltd. | 07/21/2023SE |
| K213100 | FMT Reusable Temperature ProbesFLL · Traditional | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd.… | 07/18/2023SE |
| K210924 | e-Celsius Medical SystemFLL · Traditional | Bodycap | 06/28/2023SE |
| K223522 | NC° Thermometer (Gen 3), Model Number: NCTG3FLL · Traditional | Xiamen Intretech, Inc. | 06/20/2023SE |
| K222248 | Infrared ThermometerFLL · Traditional | Alicn Medical Shenzhen, Inc. | 06/07/2023SE |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | Circa Scientific, Inc. | 05/25/2023SE |
| K223044 | Digital Thermometer (Model QT001)FLL · Traditional | Shen Zhen Rong Feng Technology Co., Ltd. | 05/10/2023SE |
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1FLL · Traditional | Iweecare Co., Ltd. | 02/17/2023SE |
| K220276 | Infrared Thermometer TET-351FLL · Traditional | Truly Instrument Limited | 02/17/2023SE |
| K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)FLL · Traditional | Zhejiang Rongsheng Industrial Co., Ltd. | 02/10/2023SE |
| K214077 | Digital Thermometer, Model: DT007, DT008FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 01/20/2023SE |
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 12/20/2022SE |
| K221800 | Infrared Thermometer (Model: Y20001, Y20002)FLL · Traditional | Zhangzhou Easepal Medical Science and Technology… | 12/14/2022SE |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304FLL · Traditional | Jkh Health Co., Ltd. | 11/28/2022SE |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 10/07/2022SE |
| K221211 | Infrared thermometerFLL · Traditional | Shenzhen Yolanda Technology Co., Ltd. | 09/27/2022SE |
| K220084 | Infrared Forehead ThermometerFLL · Traditional | Qingdao Yasee Medical Device Co., Ltd. | 09/12/2022SE |
| K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EFLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 05/25/2022SE |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241FLL · Traditional | Alicn Medical Shenzhen, Inc. | 05/12/2022SE |
| K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618FLL · Traditional | Shenzhen Pango Medical Electronics Co., Ltd. | 05/05/2022SE |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1…FLL · Traditional | Alicn Medical Shenzhen, Inc. | 05/05/2022SE |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241…FLL · Traditional | Alicn Medical Shenzhen, Inc. | 05/04/2022SE |
| K213746 | Digital thermometer, Model DT101, DT102FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 04/05/2022SE |
| K213011 | Infrared Thermometer (model: E201)FLL · Traditional | Bioland Technology, Ltd. | 04/05/2022SE |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional | Taidoc Technology Corporation | 04/05/2022SE |
| K210171 | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)FLL · Traditional | Sichuan Youkede Medical Equipment Co.,Ltd | 03/18/2022SE |
| K213038 | Infrared Forehead Thermometer, model: HS-9802DFLL · Traditional | Jiaxing Shangjia Intelligence Technology Co., Ltd. | 03/10/2022SE |
| K212945 | Sterile Disposable Temperature ProbeFLL · Traditional | Shenzhen Envisen Industry Co., Ltd. | 03/01/2022SE |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)FLL · Traditional | Microlife Intellectual Property GmbH | 03/01/2022SE |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 02/25/2022SE |
| K213079 | Ear Thermometer, Model ET001FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 02/18/2022SE |
| K213082 | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 01/28/2022SE |
| K212598 | iHealth infrared Ear thermometer PT5FLL · Abbreviated | Andon Health Co, Ltd. | 01/28/2022SE |
| K211752 | Infrared ThermometerFLL · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 01/21/2022SE |
| K210564 | Infrared ThermometerFLL · Traditional | Alicn Medical Shenzhen, Inc. | 01/07/2022SE |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | Circa Scientific, LLC | 12/17/2021SE |
| K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27…FLL · Traditional | Kangfu Medical Equipment Factory | 12/10/2021SE |
| K211629 | Infrared forehead thermometer LD-FT-100BFLL · Traditional | Honsun (Nantong) Co., Ltd. | 12/08/2021SE |
| K211744 | Non-Contact Infrared Thermometer, model HL710HFLL · Traditional | Health & Life Co., Ltd. | 11/24/2021SE |
| K201032 | Phoenix Digital ThermometerFLL · Traditional | Phoenix Innovative Healthcare Manufacturers Pvt.… | 10/29/2021SE |
| K203497 | Infrared Thermometer (Model K9)FLL · Traditional | Kangzhan Communication Electronics Co., Ltd. | 10/08/2021SE |
| K202481 | ThermArt (Model IR-EFT)FLL · Traditional | Comper Chuangxiang (Beijing) Technology Co., Ltd. | 09/28/2021SE |
| K203731 | DT100 Digital ThermometerFLL · Traditional | Smart Technology Co., Ltd. | 09/26/2021SE |
| K203662 | Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11FLL · Traditional | Yibin Junxin Electronics Technology Co., Ltd. | 09/23/2021SE |
| K211931 | Medline Digital Thermometer Non-Lubricated Probe SheathFLL · Traditional | Medline Industries, Inc. | 09/20/2021SE |
| K210118 | INFRARED BODY THERMOMETER (Model: YK-001)FLL · Traditional | Longnan Renzhong Medical Equipment Co., Ltd. | 09/15/2021SE |
| K211352 | Electronic Thermometer (XHF2001, XHF2002)FLL · Traditional | Putian Hanjiang Huafeng Plastic Co., Ltd. | 09/09/2021SE |
| K211583 | Infrared Thermometer, Model: HW-1FLL · Traditional | Dongguan Simzo Electronic Technology Co., Ltd. | 09/03/2021SE |
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS…FLL · Traditional | Jkh USA, LLC | 08/31/2021SE |
| K203643 | Sensatronic Reusable Temperature ProbesFLL · Traditional | Sensatronic GmbH | 08/11/2021SE |
| K203431 | Disposable Ear Thermometer Probe CoverFLL · Traditional | Huaian Zhongxin Packing Material Co., Ltd. | 07/28/2021SE |
| K202296 | Infrared Forehead Thermometer, Model BSX976FLL · Traditional | Shenzhen Bsx Technology Electronics Co., Ltd. | 07/23/2021SE |
| K202603 | Temp PalFLL · Traditional | Iweecare Co., Ltd. | 07/22/2021SE |
| K202741 | Infrared Forehead ThermometerFLL · Traditional | Shenzhen Combei Technology Co., Ltd. | 07/07/2021SE |
| K202440 | Infrared ThermometerFLL · Traditional | Shenzhen Sonida Digital Technology Co., Ltd. | 06/17/2021SE |
| K203215 | Radius T wearable thermometerFLL · Traditional | Masimo Corporation | 06/11/2021SE |
| K210014 | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)FLL · Traditional | Guandong Genial Technology Co., Limited | 06/04/2021SE |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200FLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 05/20/2021SE |
| K203454 | Infrared ThermometerFLL · Traditional | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 04/29/2021SE |
| K203170 | Infrared Thermometer Models: DT-8806S, DT-8807SFLL · Traditional | Shenzhen Everbest Machinery Industry Co., Ltd. | 04/16/2021SE |
| K201879 | Digital Thermometer Model T103, T104FLL · Traditional | Bioland Technology, Ltd. | 03/31/2021SE |
| K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009…FLL · Traditional | Shenzhen Juzhong Technology Co., Ltd. | 03/22/2021SE |
| K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603FLL · Traditional | Shenzhen Zhengkang Technology Co., Ltd. | 03/12/2021SE |
| K202591 | Body Infrared Thermometer HT-820DFLL · Traditional | Dongguan Xintai Instrument Co., Ltd. | 03/09/2021SE |
| K201508 | Infrared ThermometerFLL · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 03/09/2021SE |
| K202753 | iHealth Wireless No-Touch Forehead ThermometerFLL · Traditional | Andon Health Co, Ltd. | 03/08/2021SE |
| K202111 | Medical infrared forehead thermometerFLL · Traditional | Hunan Honggao Electronic Technolofy Co., Ltd. | 02/26/2021SE |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CFLL · Special | Hetaida Technology Co., Ltd. | 02/25/2021SE |
| K202420 | Infrared Forehead ThermometerFLL · Traditional | Conmo Electronic Company Limited | 02/25/2021SE |
| K202687 | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60FLL · Traditional | Shenzhen Lepu Intelligent Medical Equipment Co.… | 02/18/2021SE |
| K202368 | Infrared ThermometerFLL · Traditional | Shandong Bittel Intelligent Technology Co., Ltd. | 02/12/2021SE |
| K201536 | Infrared Forehead ThermometerFLL · Traditional | Hangzhou Qingyuan Medical Equipment Technology… | 02/10/2021SE |
| K203747 | Non-Contact Forehead Thermometer (Models UT306H & UT308H)FLL · Traditional | Uni-Trend Technology (China) Co., Ltd. | 01/25/2021SE |
| K203656 | Non-Contact Forehead Thermometer (UT30H)FLL · Traditional | Uni-Trend Technology (China) Co., Ltd. | 01/22/2021SE |
| K201582 | Non-contact Electronic Forehead Infrared ThermometerFLL · Traditional | Zhongshan Jinli Electronic Weighing Equipment… | 01/15/2021SE |
| K201579 | Infrared ThermometerFLL · Traditional | Shenzhen Xunwei Industrial Co., Ltd. | 01/15/2021SE |
| K202791 | iHealth Clinical Digital ThermometerFLL · Abbreviated | Andon Health Co, Ltd. | 01/05/2021SE |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823USFLL · Traditional | Hetaida Technology Co., Ltd. | 01/05/2021SE |
| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | Deroyal Industries, Inc. | 12/23/2020SE |
| K201980 | Infrared ThermometerFLL · Traditional | Contec Medical Systems Co.,Ltd | 12/18/2020SE |
| K191978 | Fever GardeFLL · Traditional | Hubdic Co., Ltd. | 12/18/2020SE |
| K200781 | Infrared Body ThermometerFLL · Traditional | Heitaida Technology Co., Ltd. | 12/09/2020SE |
| K201864 | YUWELL Infrared ThermometerFLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 12/07/2020SE |
| K201977 | TempTraqFLL · Traditional | Blue Spark Technologies, Inc. | 12/03/2020SE |
| K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)FLL · Traditional | Dongguan E-Test Technology Co., Ltd. | 11/23/2020SE |
| K201843 | Infrared ear and forehead thermometer, model YI-100FLL · Traditional | Wenzhou Yosun Medical Technology Co.,Ltd | 10/23/2020SE |
| K200802 | Infrared ThermometerFLL · Traditional | Shenzhen Urion Technology Co., Ltd. | 10/07/2020SE |
| K201161 | Infrared Thermometer Model E127FLL · Traditional | Bioland Technology, Ltd. | 10/02/2020SE |
| K200710 | Infrared PT2L Digital No-Touch ThermometerFLL · Abbreviated | Andon Health Co, Ltd. | 10/01/2020SE |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesFLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 08/25/2020SE |
| K193625 | Disposable Temperature ProbeFLL · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 07/24/2020SE |
| K200578 | Infrared Thermometer Model Number RN-50A,RN-50BFLL · Traditional | Ningbo Ranor Medical Science & Technology Co.… | 07/16/2020SE |
| K200531 | iHealth Infrared No-Touch Forehead ThermometerFLL · Traditional | Andon Health Co, Ltd. | 07/15/2020SE |
| K200599 | Digital ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 07/08/2020SE |
| K200471 | Infrared Thermometer Model Number RN-60A,RN-60BFLL · Traditional | Ningbo Ranor Medical Science & Technology Co.… | 06/19/2020SE |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503FLL · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/17/2020SE |
| K193213 | Vicks VNT200 No Touch Forehead ThermometerFLL · Traditional | Kaz USA, Inc., A Helen of Troy Company | 04/28/2020SE |
| K190984 | Infrared Forehead ThermometerFLL · Traditional | Xiamen Ants Bro Technology Co., Ltd. | 04/22/2020SE |
| K191829 | Microlife Non-Contact Infrared Forehead ThermometerFLL · Traditional | Microlife Intellectual Property GmbH | 02/13/2020SE |
| K190990 | Digital ThermometerFLL · Traditional | Xiamen Ants Bro Technology Co., Ltd. | 12/31/2019SE |
| K190717 | Infrared Thermometer, model: PC808FLL · Traditional | Shenzhen Pacom Medical Instruments Co., Ltd. | 12/13/2019SE |
| K183393 | Digital ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 11/18/2019SE |
| K191570 | Infrared Thermometer Model MD-H30FLL · Traditional | Guangzhou Berrcom Medical Device Co., Ltd. | 11/13/2019SE |
| K191668 | Infrared Forehead Thermometer (Model IR-FT)FLL · Traditional | Comper Chuangxiang (Beijing) Technology Co., Ltd. | 10/18/2019SE |
| K191283 | Infrared Thermometer, Breeze modelFLL · Traditional | Suzhou Melodicare Medical Technology Co., Ltd. | 10/18/2019SE |
| K191251 | Infared ThermometerFLL · Traditional | Shenzhen Calibeur Industries Co., Ltd. | 10/15/2019SE |
| K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | Fiab Spa | 10/10/2019SE |
| K182751 | Reusable Temperature ProbeFLL · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 09/06/2019SE |
| K191004 | Advocate Non-Contact Infrared ThermometerFLL · Traditional | Broadmaster Biotech, Corp. | 09/05/2019SE |
| K190873 | Infrared Ear/Forehead ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 07/26/2019SE |
| K183663 | Microlife Digital Infrared Ear ThermometerFLL · Special | Microlife Intellectual Property GmbH | 07/16/2019SE |
| K182667 | Med-link Temperature ProbesFLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 06/18/2019SE |
| K183431 | Medline Digital Rectal Thermometer SheathFLL · Traditional | Medline Industries, Inc. | 06/14/2019SE |
| K182437 | Wireless Intelligent ThermometerFLL · Traditional | Shenzhen Jumper Medical Equipment Co., Ltd. | 05/05/2019SE |
| K182597 | Infrared thermometerFLL · Traditional | Shenzhen Pango Electronic Co., Ltd. | 04/03/2019SE |
| K190242 | Tyto ThermometerFLL · Traditional | Tyto Care , Ltd. | 03/27/2019SE |
| K182629 | Digital ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 02/28/2019SE |
| K180767 | FEMON Banana ThermometerFLL · Traditional | Life Science Technology, Inc. | 01/22/2019SE |
| K180387 | Infrared Ear ThermometerFLL · Traditional | Hetaida Technology Co., Ltd. | 01/10/2019SE |
| K180355 | Advocate Non-Contact Infrared ThermometerFLL · Traditional | Broadmaster Biotech, Corp. | 01/10/2019SE |
| K181215 | Infrared ThermometerFLL · Traditional | Shenzhen Finicare Co., Ltd. | 01/02/2019SE |
| K182755 | Disposable Temperature ProbeFLL · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 12/21/2018SE |
| K181967 | Disposable Temperature ProbeFLL · Traditional | Shenzhen Launch Electrical Co., Ltd. | 12/10/2018SE |
| K173048 | No-contact Forehead ThermometerFLL · Traditional | Dongguan Simzo Electronic Technology Co., Ltd. | 12/06/2018SE |
| K163601 | RII Smart IR ThermometerFLL · Traditional | Radiant Innovation, Inc. | 12/06/2018SE |
| K180298 | welloStationXFLL · Traditional | Wello, Inc. | 11/30/2018SE |
| K180207 | Non-contact Infrared ThermometerFLL · Traditional | Alicn Medical (Shenzhen), Inc. | 11/28/2018SE |
| K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08…FLL · Traditional | Kangfu Medical Equipment Factory | 11/20/2018SE |
| K182133 | Infrared ThermometerFLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 11/20/2018SE |
| K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | Fiab Spa | 11/08/2018SE |
| K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 10/29/2018SE |
| K170723 | Swaive Thermometer SWT1AFLL · Traditional | E-Care Technology Co., Ltd. | 10/25/2018SE |
| K172733 | TD-1035 ThermometerFLL · Traditional | Taidoc Technology Corporation | 10/22/2018SE |
| K173194 | Temperature ProbeFLL · Traditional | Orantech, Inc. | 10/10/2018SE |
| K181081 | Infrared Ear ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 10/02/2018SE |
| K180714 | Probe Covers for ThermometersFLL · Abbreviated | K-Jump Health Co., Ltd. | 09/24/2018SE |
| K181013 | Fever ScoutFLL · Traditional | VivaLNK, Inc. | 08/21/2018SE |
| K180131 | Vicks RapidRead Digital ThermometerFLL · Traditional | Kaz USA, Inc., A Helen of Troy Company | 08/14/2018SE |
| K172508 | Ageless Health Medical Digital ThermometerFLL · Traditional | Ageless Health Industrial Co., Ltd. | 08/08/2018SE |
| K181242 | Braun BNT400 No Touch + Forehead ThermometerFLL · Special | Kaz USA, Inc., A Helen of Troy Company | 07/23/2018SE |
| K171888 | Non-contact infrared body thermometerFLL · Traditional | Hetaida Technology Co., Ltd. | 07/23/2018SE |
| K181015 | Braun BFH175 Infrared Forehead ThermometerFLL · Special | Kaz USA, Inc., A Helen of Troy Company | 07/18/2018SE |
| K172874 | Infrared ThermometerFLL · Traditional | Shenzhen Jiacom Technology CO ., Ltd. | 07/12/2018SE |
| K180314 | Infrared ThermometerFLL · Traditional | Xuzhou Yongkang Electronic Science Technology… | 07/11/2018SE |
| K172121 | Digital ThermometerFLL · Traditional | Fudakang Industrial Co., Ltd. | 06/07/2018SE |
| K172889 | Infrared ThermometerFLL · Traditional | Shenzhen Pacom Medical Instruments Co., Ltd. | 05/25/2018SE |
| K172894 | Infrared ThermometerFLL · Traditional | Shenzhen Jiacom Technology CO ., Ltd. | 05/17/2018SE |
| K180385 | Infrared Body ThermometerFLL · Traditional | Hetaida Technology Co., Ltd. | 05/11/2018SE |
| K172427 | AViTA Radar Thermo NT16 Series IR ThermometerFLL · Traditional | Avita Corporation | 04/19/2018SE |
| K180148 | ATS Thermal Imaging Probe, ATS Patient Interface UnitFLL · Special | Securus Medical Group, Inc. | 03/21/2018SE |
| K172795 | Infrared ThermometerFLL · Traditional | Shenzhen Jumper Medical Equipment Co., Ltd. | 03/14/2018SE |
| K171214 | Infrared ThermometerFLL · Traditional | Shenzhen Brav Electronic Technologies Co., Ltd. | 03/02/2018SE |
| K172870 | Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I…FLL · Special | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 02/13/2018SE |
| K171455 | AT-6XX Series Infrared ThermometerFLL · Traditional | Xiamen Acurio Instruments Co., Ltd. | 02/09/2018SE |
| K173730 | Kinsa QuickCare ThermometerFLL · Traditional | Kinsa, Inc. | 01/17/2018SE |
| K173113 | Medline Disposable Electronic Thermometer Probe CoverFLL · Traditional | Medline Industries, Inc. | 01/17/2018SE |
| K172861 | Digital thermometer(with disposable thermometer cover)FLL · Special | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 12/19/2017SE |
| K171578 | Infrared thermometerFLL · Traditional | Shenzhen Aeon Technology Co., Ltd. | 11/30/2017SE |
| K170662 | Non Contact Infrared Forehead ThermometerFLL · Traditional | Intrinity Global Limited | 11/22/2017SE |
| K171182 | ri-former Predictive ThermometerFLL · Traditional | Rudolf Riester GmbH | 10/04/2017SE |
| K170262 | Digital ThermometerFLL · Abbreviated | K-Jump Health Co., Ltd. | 09/28/2017SE |
| K163518 | Digital ThermometerFLL · Traditional | Joytech Healthcare Co. , Ltd. | 09/19/2017SE |
| K170769 | wireless thermometerFLL · Traditional | Ech (Changzhou) Medical Instrument Co., Ltd. | 07/26/2017SE |
| K170219 | Microlife Digital Infrared Ear ThermometerFLL · Traditional | Microlife Intellectual Property GmbH | 07/20/2017SE |
| K163603 | Digital ThermometerFLL · Traditional | Guangzhou Jinxinbao Electronic Co., Ltd. | 06/06/2017SE |
| K163516 | Braun No Touch + Forehead NTF3000 ThermometerFLL · Special | Kaz USA, Inc., A Helen of Troy Company | 04/21/2017SE |
| K160680 | VisioFocus Mini, VisioFocus SmartFLL · Traditional | Tecnimed S.R.L. | 04/19/2017SE |
| K163256 | Dual Mode Infrared ThermometerFLL · Traditional | Intelliworks, LLC | 04/06/2017SE |
| K162509 | Infrared Non-contact Thermometer, Model ACT8100FLL · Traditional | Easywell Biomedicals, Inc. | 03/10/2017SE |
| K160358 | DT-100FLL · Traditional | Mediana Co., Ltd. | 02/24/2017SE |
| K162137 | Fever Scout Continuous Monitoring thermometerFLL · Traditional | VivaLNK, Inc. | 01/19/2017SE |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52ZFLL · Traditional | Radiant Innovation, Inc. | 01/09/2017SE |
| K160306 | Cloud Smart ThermometerFLL · Traditional | Guangzhou Bosma Technology Co, Ltd. | 12/13/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3256-2026 | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesMyocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead… | DeRoyal Industries Inc | 08/20/2026Open, Classified |
| Z-0233-2026 Class II | Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690…Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected… | Baxter Healthcare Corporation | 09/17/2025Open, Classified |
| Z-2339-2024 Class II | Braun Thermoscan PRO 6000 Ear ThermometerThe Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an… | Baxter Healthcare Corporation | 06/13/2024Open, Classified |
| Z-2482-2021 Class II | Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of…If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there… | Welch Allyn Inc | 07/20/2021Open, Classified |
| Z-0994-2020 Class II | Genius 2 Tympanic Thermometer Private Label Item Code: 3069The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | Cardinal Health 200, LLC | 10/28/2019Terminated |
| Z-0993-2020 Class II | Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | Cardinal Health 200, LLC | 10/28/2019Terminated |
| Z-0992-2020 Class II | Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | Cardinal Health 200, LLC | 10/28/2019Terminated |
| Z-0991-2020 Class II | Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | Cardinal Health 200, LLC | 10/28/2019Terminated |
| Z-0990-2020 Class II | Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not… | Cardinal Health 200, LLC | 10/28/2019Terminated |
| Z-0689-2018 Class II | Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)Device may provide inaccurate measurements. | Philips Consumer Lifestyle | 02/02/2018Terminated |
| Z-0114-2018 Class II | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360…During a recent investigation, 3M confirmed that a programming translation error could occur in a small… | 3M Company - Health Care Business | 10/17/2017Terminated |
| Z-0395-2018 Class II | Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as…The reusable temperature probes are provided with instructions for sterilization that have not been proven… | Measurement Specialties Inc | 03/13/2017Open, Classified |
| Z-0412-2016 Class II | Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen)…An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently… | Bestmed, LLC | 11/12/2015Terminated |
| Z-1959-2013 Class II | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per…GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9… | Vital Signs Devices, a GE Healthcare Company | 07/18/2013Terminated |
| Z-0506-2012 | Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model…The thermometers have been reported to have inaccurate readings | Walgreen Company | 11/23/2011Terminated |