Blood Pressure Cuff
FDA product code DXQ · Class II (moderate risk) · 21 CFR 870.1120 · Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
199510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Rudolf Riester GmbH & Co. KG 8
- Conphar, Inc. 6
- Abco Dealers, Inc. 5
- Pymah Corp. 5
- Welch Allyn, Inc. 4
- Ethox Corp. 4
- Unimed Medical Supplies, Inc. 4
- Ge Medical Systems Information Technologies 4
- Vital Signs, Inc. 3
- Pedia Pals, Inc. 3
- Hewlett-Packard Co. 3
- Howmedica Corp. 3
- Medline Industries, LP 3
- Frontier Products 2
- DeRoyal Industries Inc 2
- Golden Horse Medical Equipment (Wuxi) Co. , Ltd. 2
- Statcorp, Inc. 2
- Biomet, Inc. 2
- Med-Con, Inc. 2
- Depuy, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,12…DXQ · Traditional | Shenzhen Plinma Technology Co. , Ltd. | 11/29/2023SE |
| K231961 | NIBPCuffDXQ · Traditional | Shenzhen Sino-K Medical Technology Co.,Ltd | 08/30/2023SE |
| K230859 | Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Kangshun Medical Devices Co.,Ltd | 06/28/2023SE |
| K230145 | One-CufDXQ · Traditional | Ge Medical Systems Information Technologies, Inc. | 03/14/2023SE |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid SphygmomanometerDXQ · Traditional | Cardicare Company, Ltd. | 11/28/2022SE |
| K222420 | Disposable Blood Pressure CuffDXQ · Traditional | Wenzhou Xikang Medical Instruments Co., Ltd. | 11/21/2022SE |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20…DXQ · Traditional | Zhejiang Lude Technology Development Co., Ltd. | 10/13/2022SE |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter…DXQ · Traditional | Wenzhou Xikang Medical Instruments Co., Ltd. | 05/18/2022SE |
| K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeDXQ · Traditional | Shanghai Caremate Medical Device Co., Ltd. | 10/19/2021SE |
| K211747 | Reusable NIBP CuffDXQ · Traditional | Shenzhen Coreray Technology Co., Ltd. | 09/23/2021SE |
| K203620 | Aneroid SphygmomanometerDXQ · Traditional | Wuxi Exanovo Medical Instrument Co., Ltd. | 03/23/2021SE |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff…DXQ · Traditional | Jkh USA, LLC | 01/06/2021SE |
| K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ · Traditional | Little Doctor Electronic (Nantong)Co.,Ltd | 07/02/2020SE |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ · Traditional | Honsun (Nantong) Co., Ltd. | 04/06/2020SE |
| K193629 | Disposable NIBP CuffDXQ · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 03/25/2020SE |
| K191253 | Reusable NIBP CuffDXQ · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 09/17/2019SE |
| K191209 | Aneroid Type Blood Pressure KitDXQ · Traditional | Dongguan Mars Medical Products Co., Ltd. | 06/18/2019SE |
| K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with…DXQ · Traditional | Wenzhou Renhua Instruments Co., Ltd. | 05/22/2019SE |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffDXQ · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 12/17/2018SE |
| K173197 | Reusable NIBP CuffDXQ · Traditional | Orantech, Inc. | 08/21/2018SE |
| K173869 | Med-link Reusable Blood Pressure CuffDXQ · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 08/02/2018SE |
| K173246 | Aneroid SphygmomanometerDXQ · Abbreviated | Wenzhou Bokang Instruments Co., Ltd. | 05/30/2018SE |
| K180335 | Accutension Smartphone Auscultatory BloodDXQ · Traditional | Shanghai Hulu Devices Co., Ltd. | 03/08/2018SE |
| K171889 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/19/2017SE |
| K173044 | Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffDXQ · Traditional | Ningbo Albert Novosino Co., Ltd. | 11/20/2017SE |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffDXQ · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 11/28/2016SE |
| K161035 | Medline Singe Patient Use Blood Pressure CuffDXQ · Traditional | Medline Industries, Inc. | 06/13/2016SE |
| K152006 | Cogent Hemodynamic Monitoring SystemDXQ · Traditional | Icu Medical, Inc. | 05/05/2016SE |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure CuffDXQ · Traditional | Ningbo Free Trade Zone Tenso Medical Instruments… | 04/14/2016SE |
| K151810 | Bpump Blood Pressure CuffDXQ · Traditional | Shenzhen Pump Medical System Co., Ltd. | 12/17/2015SE |
| K152468 | Reusable Blood Pressure CuffDXQ · Traditional | Shenzhen Vistar Medical Supplies Co., Ltd. | 10/29/2015SE |
| K152465 | Disposable Blood Pressure CuffDXQ · Traditional | Shenzhen Vistar Medical Supplies Co., Ltd. | 10/29/2015SE |
| K152801 | Ultracheck Spacelabs Abp Cuff-Child, Ultracheck Spacelabs Abp Cuff-Small Adult…DXQ · Special | Statcorp Medical | 10/27/2015SE |
| K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff…DXQ · Special | Philips Medical Systems | 10/27/2015SE |
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffDXQ · Traditional | Xuzhou Maicuff Technology Co., Ltd. | 06/30/2015SE |
| K151246 | Aneroid SphygmomanometerDXQ · Traditional | Jiaxing Zhongfa Medical Products Co., Ltd. | 06/30/2015SE |
| K143728 | Minhua Disposable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus | 05/15/2015SE |
| K143332 | Fast Sphyg by KovenDXQ · Traditional | Koven Technology, Inc. | 04/14/2015SE |
| K150227 | Disposable Blood Pressure Cuff GuardDXQ · Traditional | Pinhu Sama Medical Packing Co., Ltd. | 04/02/2015SE |
| K141998 | Sama Disposable Blood Pressure Cuff BarriersDXQ · Traditional | Pinghu Sama Medical Packing Co., Ltd. | 09/19/2014SE |
| K140874 | GH Disposable and GH Reusable Blood Pressure CuffDXQ · Traditional | Shanghai Goahui Rubber and Plastic Company | 09/02/2014SE |
| K141392 | SphygmomanometerDXQ · Traditional | Suzhou JJ Meter Co., Ltd. | 07/02/2014SE |
| K133117 | Andon Blood Pressure CuffDXQ · Traditional | Andon Health Co, Ltd. | 03/04/2014SE |
| K130942 | Legacy Medical Eco-Choice Disposable Blood Pressure CuffDXQ · Traditional | Legacy Medical, Inc. | 10/17/2013SE |
| K123996 | Radial-Cuf Non-Invasive Blood Pressure CuffDXQ · Traditional | Ge Medical Systems Information Technologies, Inc. | 04/09/2013SE |
| K122058 | Flexiport EcocuffDXQ · Traditional | Welch Allyn, Inc. | 11/05/2012SE |
| K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufDXQ · Traditional | Ge Medical Systems Information Technologies, Inc. | 10/03/2012SE |
| K122259 | Blood Pressure Monitor with StethoscopeDXQ · Traditional | Hangzhou Reli-On Co., Ltd. | 09/24/2012SE |
| K120364 | Unimed Disposable Blood Pressure CuffDXQ · Traditional | Unimed Medical Supplies, Inc. | 05/04/2012SE |
| K112544 | Unimed Blood Pressure CuffDXQ · Traditional | Unimed Medical Supplies, Inc. | 11/22/2011SE |
| K103637 | Erka. Perfect-AneroidDXQ · Traditional | Erka Kallmeyer Medizintechnik GmbH | 06/08/2011SE |
| K102825 | Blood Pressure CuffDXQ · Traditional | APK Technology Co., Ltd. | 03/02/2011SE |
| K102792 | Disposable Blood Pressure CufDXQ · Traditional | Caremate Medical Device Co., Ltd. | 01/26/2011SE |
| K102823 | Disposable Blood Pressure CuffDXQ · Traditional | Wuxi Medical Instrument Factory | 01/07/2011SE |
| K101892 | Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma XXL LF…DXQ · Traditional | Heine Optotechnik GmbH & Co. KG | 08/27/2010SE |
| K101972 | Solaris Reusable and Disposable Blood Pressure CuffsDXQ · Traditional | Solaris Medical Technology, Inc. | 07/22/2010SE |
| K092999 | NBP CuffDXQ · Traditional | Draeger Medical AG & Co. KG | 11/24/2009SE |
| K092245 | Aneroid Sphygmomanometer with Stethoscope, Model LD-100DXQ · Traditional | Honsun (Nantong) Co., Ltd. | 10/28/2009SE |
| K092604 | Large Face Aneroid Sphygmomanometer, Wall Model, Desk Model, Mobile Stand Model, Model…DXQ · Abbreviated | Trimline Medical Products Corp. | 10/21/2009SE |
| K090014 | Caremate Sphygmomanometer with StethoscopeDXQ · Traditional | Caremate Medical Device Co., Ltd. | 04/09/2009SE |
| K090664 | Devon Accubp CuffDXQ · Traditional | Devon Medical, Inc. | 03/23/2009SE |
| K082630 | Vitalcheck Blood Pressure Cuff, Model ZVC4000 SeriesDXQ · Abbreviated | Zefon Intl. | 12/19/2008SE |
| K080854 | Disposable Blood Pressure Cuff, Model DC100DXQ · Abbreviated | Suntech Medical, Inc. | 10/20/2008SE |
| K082542 | Aneroid Sphygmomanometer with Stethoscope Model Hbpk-ADXQ · Traditional | Cardicare Company, Ltd. | 09/17/2008SE |
| K081951 | Aneroid Sphygmomanometer, Model KT-A01DXQ · Traditional | Wenzhou Kindcare Import & Export Co., Ltd. | 08/15/2008SE |
| K080189 | Tempa-Kuff Soft Blood Pressure Cuff, Model 39XXX ; Vinyl,Model 99XXXDXQ · Abbreviated | Trimline Medical Products Corp. | 08/15/2008SE |
| K080366 | Duracheck Blood Pressure Cuff, Model ZDC4000 SeriesDXQ · Abbreviated | Zefon Intl. | 06/09/2008SE |
| K071244 | Medline Single Patient Use Blood Pressure CuffDXQ · Traditional | Medline Industries, Inc. | 03/05/2008SE |
| K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood…DXQ · Traditional | Welch Allyn, Inc. | 12/18/2007SE |
| K063863 | Advantage Cuff, Non-Invasive Blood Pressure Hose and AdapterDXQ · Traditional | Advantage Medical Cables, Inc. | 03/20/2007SE |
| K062238 | Tytan Blood Pressure CuffDXQ · Traditional | Tytan Medical Corp. | 09/21/2006SE |
| K061962 | Surgi-Cuf Reusable, RS SeriesDXQ · Traditional | Ethox International | 07/25/2006SE |
| K060871 | AS101, Blood Pressure CuffDXQ · Traditional | Wenzhou Longwan Medical Instrument Company | 06/09/2006SE |
| K053006 | Rossmax Digital Sphygmomanometer Mandaus IIDXQ · Traditional | Rossmax Internationl , Ltd. | 02/03/2006SE |
| K051904 | All Purpose Cuff, Model 222APCDXQ · Abbreviated | Suntech Medical, Inc. | 09/09/2005SE |
| K051539 | Tricot Blood Pressure CuffDXQ · Traditional | Ya Horng Electronic Co., Ltd. | 08/05/2005SE |
| K051021 | Aneroid Sphygmanometer with Stethoscope, Model HS-50ADXQ · Abbreviated | Shanghai Lord International Trade Co., Ltd. | 06/20/2005SE |
| K043444 | Multiple, Model KTJ-50DXQ · Traditional | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 02/22/2005SE |
| K043286 | Aneroid Sphygmomanometer, Model BK2002DXQ · Traditional | Wenzhou Bokang Instrument Co.,Ltd | 01/13/2005SE |
| K041689 | Polyurethane Blood Pressure CuffsDXQ · Special | D. E. Hokanson, Inc. | 08/06/2004SE |
| K032568 | BP Cuff Barrier 1081789, BP Cuff Barrier, Plastic Coated 1030193DXQ · Traditional | Med Textile, LLC | 04/29/2004SE |
| K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure CuffsDXQ · Abbreviated | Ethox Corp. | 03/15/2004SE |
| K031195 | Cuf-Cover (TM)DXQ · Traditional | Ethox Corp. | 10/10/2003SE |
| K031416 | Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffDXQ · Traditional | Clearmedical, Inc. | 07/15/2003SE |
| K023356 | Klock Watch Style Digital Blood Pressure MonitorDXQ · Traditional | Card Guard Scientific Survival , Ltd. | 01/16/2003SE |
| K022482 | Sensa-Cuff, Models Infant, Child, AdultDXQ · Traditional | Ge Medical Systems Information Technologies | 08/13/2002SE |
| K012553 | Gsibp Blood Pressure CuffDXQ · Abbreviated | Globalshop, Inc. | 08/17/2001SE |
| K012455 | Welch Allyn Durashock Blood Pressure SystemDXQ · Abbreviated | Welch Allyn, Inc. | 08/17/2001SE |
| K012444 | Abn Aneroid SphygmomanometerDXQ · Traditional | Pt. Sugih Instrumendo Abadi | 08/16/2001SE |
| K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110DXQ · Traditional | Nihon Seimitsu Sokki Co., Ltd. | 07/20/2001SE |
| K010686 | KTJ-20C Blood Pressure Cuff, Model KTJ-20CDXQ · Abbreviated | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 03/21/2001SE |
| K003415 | Aneroid Sphygmomanometer with StethoscopeDXQ · Traditional | Wang & Li, Inc. | 01/03/2001SE |
| K002955 | Empire N Blood Pressure ManometersDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 12/21/2000SE |
| K002954 | Ri-San/Ri-Sana Blood Pressure ManometersDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 12/21/2000SE |
| K002360 | Cloud CuffDXQ · Traditional | Parts Port, Ltd. | 09/26/2000SE |
| K000512 | Oscillomitt, Models CM 1050, CM 1040, CM 1030, CM 1020, CM 1010DXQ · Traditional | Cas Medical Systems, Inc. | 09/26/2000SE |
| K994044 | Cleen-AbleDXQ · Traditional | Vital Signs, Inc. | 02/25/2000SE |
| K991545 | Watch Style Wrist Digital Blood Pressure Monitor, Model: KlockDXQ · Traditional | Industrielle Entwicklung Medizintechnik Und Vertri | 01/19/2000SE |
| K990412 | Cuff-Able PlusDXQ · Traditional | Vital Signs, Inc. | 09/01/1999SE |
| K991525 | Deroyal Sterile Neonatal Blood Pressure CuffDXQ · Traditional | Deroyal Industries, Inc. | 07/20/1999SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | Cypress Medical Products, Ltd. | 07/07/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | Johnson & Johnson Medical, Inc. | 05/18/1998SE |
| K972379 | Precisa NDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 09/24/1997SE |
| K972378 | Sanaphon NDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 09/24/1997SE |
| K972377 | Ri-MegaDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 09/24/1997SE |
| K972301 | Big Ben Square, Big Ben RoundDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 09/17/1997SE |
| K963987 | Camouflage Cuff SaversDXQ · Traditional | N.A. Braggs Medical, Inc. | 07/23/1997SE |
| K964648 | Protect All Blood Pressure Cuff CoverDXQ · Traditional | Protect All, Inc. | 02/18/1997SE |
| K962655 | Aneroid and Mercurial SphygmomanometersDXQ · Traditional | American Diagnostic Corp. | 01/27/1997SE |
| K954282 | Ultracuff Blood Pressure Cuff and Inflation BagDXQ · Traditional | Statcorp, Inc. | 02/06/1996SE |
| K951041 | Blood Pressure Cuff 3DXQ · Traditional | Pedia Pals, Inc. | 10/31/1995SE |
| K951040 | Blood Pressure Cuff 2DXQ · Traditional | Pedia Pals, Inc. | 10/31/1995SE |
| K951039 | Blood Pressure Cuff 1DXQ · Traditional | Pedia Pals, Inc. | 10/31/1995SE |
| K953952 | Deroyal Industris, Inc. Blood Pressure CuffDXQ · Traditional | Deroyal Industries, Inc. | 09/28/1995SE |
| K953466 | GenericuffDXQ · Traditional | Generic Medical, Inc. | 09/15/1995SE |
| K952825 | Cuff GuardDXQ · Traditional | Bowen Medical Services, Inc. | 09/15/1995SE |
| K950778 | Medifriend Professional SphygmomanometerDXQ · Traditional | Shanghai Medifriend Medical Products Co., Ltd. | 03/14/1995SE |
| K945035 | Ocl ContourDXQ · Traditional | M-Pact Worldwide, LLC | 11/15/1994SE |
| K942259 | TechnicuffDXQ · Traditional | Technicuff Corp. | 09/06/1994SE |
| K942488 | MedcuffDXQ · Traditional | Med-Con, Inc. | 08/23/1994SE |
| K942777 | Minimus II; Minimus II Color; BabyphonDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 07/27/1994SE |
| K936313 | CMS-90 Blood Pressure Measurement AssistantDXQ · Traditional | Prevention Sciences | 07/20/1994SE |
| K940493 | Hand Aneroid SphygmomanometerDXQ · Traditional | Welch Allyn, Inc. | 07/01/1994SE |
| K940214 | Statcorp Inc. Disposable Blood Pressure CuffDXQ · Traditional | Statcorp, Inc. | 02/22/1994SE |
| K925297 | Ri-MedDXQ · Traditional | Rudolf Riester GmbH & Co. KG | 01/14/1994SE |
| K934180 | Slimline 3000DXQ · Traditional | Pymah Corp. | 11/24/1993SE |
| K932851 | Disposable Penile Blood Pressure CuffsDXQ · Traditional | D. E. Hokanson, Inc. | 11/15/1993SE |
| K925744 | Tempa-Kuff Single Pat Pre-Gaged Balanced Disp CuffDXQ · Traditional | Pymah Corp. | 07/30/1993SE |
| K931087 | Cleancuff(Tm)DXQ · Traditional | Med-Con, Inc. | 05/27/1993SE |
| K930604 | Balanced(Tm) Nylon BladderDXQ · Traditional | Pymah Corp. | 04/30/1993SE |
| K925352 | Clean Cuff Blood Pressure Cuff LinerDXQ · Traditional | Steridyne Corp. | 01/12/1993SE |
| K921997 | Cuff-MDXQ · Traditional | Lorin Medical, Inc. | 07/23/1992SE |
| K911213 | CuffableDXQ · Traditional | Biomedical Dynamics, Inc. | 08/07/1991SE |
| K912638 | Blood Pressure CuffsDXQ · Traditional | Vital Signs, Inc. | 07/25/1991SE |
| K912007 | Baxter Single Patient Use Blood Pressure CuffDXQ · Traditional | Tecnadyne Scientific, Inc. | 07/22/1991SE |
| K910903 | Inflate-A-Cuff #7014DXQ · Traditional | Pa Medical Corp. | 05/08/1991SE |
| K905147 | Adult,Sterile,Dispos.,Nonivas.,Blood Press. CuffsDXQ · Traditional | Hewlett-Packard Co. | 12/27/1990SE |
| K905101 | Neonatal/Sterile/Dispos/Noninvas Blood Press CuffDXQ · Traditional | Hewlett-Packard Co. | 12/20/1990SE |
| K903379 | Pymah Pre-Gaged Balanced Tempa-KuffDXQ · Traditional | Pymah Corp. | 10/19/1990SE |
| K901252 | Hewlett-Packard Series of Disposable Nibp CuffsDXQ · Traditional | Hewlett-Packard Co. | 07/31/1990SE |
| K902132 | Cuff, Blood PressureDXQ · Traditional | Buffalo Medical Specialties Mfg., Inc. | 06/29/1990SE |
| K901506 | Aneroid Sphygmomanometer, Doctor TypeDXQ · Traditional | Yamasu Co. , Ltd. | 05/09/1990SE |
| K896986 | Blood Pressure CuffDXQ · Traditional | Latex Medical Devices, Inc. | 03/06/1990SE |
| K896788 | Disp. Neonatal Blood Pressure Monitoring CuffDXQ · Traditional | Advanced Medical Instruments, Inc. | 01/19/1990SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | Ethox Corp. | 02/10/1989SE |
| K884421 | Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatDXQ · Traditional | Pymah Corp. | 01/13/1989SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | Biomedical Dynamics, Inc. | 10/14/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | Concept, Inc. | 06/20/1988SE |
| K874233 | Blood Pressure Sleeve W/TubingDXQ · Traditional | Devcom, Inc. | 03/22/1988SE |
| K874939 | Schurman/Carter II Hip Prosthesis, Porous CoatedDXQ · Traditional | Kirschner Medical Corp. | 02/02/1988SN |
| K872144 | Modified Digital Blood Pressure/Pulse MeterDXQ · Traditional | Vestra-Subco, Inc. | 07/29/1987SE |
| K854813 | Mednova Blood Pressure CuffDXQ · Traditional | Mednova Corp. | 06/20/1986SE |
| K854023 | Norelco Electronic Digital BP Meter HC3501DXQ · Traditional | Philips Park | 03/26/1986SE |
| K854752 | The California SplintDXQ · Traditional | Intl. Medication Systems, Ltd. | 12/17/1985SE |
| K852193 | Porocoat Schatzker II AcetabulumDXQ · Traditional | Depuy, Inc. | 07/30/1985SN |
| K852964 | P.C.A. Total Hip Femoral Component ModificationDXQ · Traditional | Howmedica Corp. | 07/29/1985SE |
| K851565 | Homedica Cemented Acetabular Component 6262DXQ · Traditional | Howmedica Corp. | 07/19/1985SE |
| K844988 | Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.DXQ · Traditional | Ethox Corp. | 04/04/1985SE |
| K831001 | Unicuff-Blood Pressure CuffDXQ · Traditional | Frontier Products | 07/28/1983SE |
| K831393 | Vasculab Blood Pressure CuffDXQ · Traditional | Medasonics, Inc. | 06/16/1983SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | Dow Corning Corp. Healthcare Industries Materials | 06/15/1983SE |
| K823843 | Freeman Acetabular CupDXQ · Traditional | Depuy, Inc. | 03/29/1983SE |
| K830097 | Aufranc-Turner Ats Metal Backed AcetabuDXQ · Traditional | Howmedica Corp. | 01/28/1983SE |
| K821095 | SphyguriteDXQ · Traditional | Associated Medical Devices, Inc. | 06/10/1982SE |
| K821232 | One Hand Aneroid SphygmomanometerDXQ · Traditional | Abco Dealers, Inc. | 05/25/1982SE |
| K820539 | Relieved Reinforced CupDXQ · Traditional | Biomet, Inc. | 03/15/1982SE |
| K813303 | Conphar, Wall Aneroid SphygmomanometerDXQ · Traditional | Conphar, Inc. | 01/22/1982SE |
| K813302 | Conphar Palm Aneroid SphygmomanometerDXQ · Traditional | Conphar, Inc. | 01/22/1982SE |
| K813323 | Thigh Cuff: X-Large CuffDXQ · Traditional | Abco Dealers, Inc. | 12/29/1981SE |
| K812946 | Tronzo HipDXQ · Traditional | Biomet, Inc. | 11/06/1981SE |
| K811634 | Norelco Aneroid Blood Pressure MeterDXQ · Traditional | North American Philips Corp. | 06/30/1981SE |
| K810838 | Neonatal Blood Pressure CuffDXQ · Traditional | Invivo Research Labs, Inc. | 04/03/1981SE |
| K810008 | Alp-KiiDXQ · Traditional | Martin'S Maine Exchange | 01/16/1981SE |
| K801568 | Shield Disposable Blood Pressure CuffDXQ · Traditional | American Convertors Div., American Pharmaseal | 07/28/1980SE |
| K801188 | Conphar Desk Top Mercury SphygmomanDXQ · Traditional | Conphar, Inc. | 06/09/1980SE |
| K801186 | Conphar Deluxe Aneroid SphygmomanometerDXQ · Traditional | Conphar, Inc. | 06/09/1980SE |
| K801182 | Conphar Wall Model Mercury Sphygmoman.DXQ · Traditional | Conphar, Inc. | 06/04/1980SE |
| K801099 | Unicuf, Blood Pressure CuffDXQ · Traditional | Frontier Products | 05/30/1980SE |
| K800767 | Mod. Mci 17 Manual Cuff InflatorDXQ · Traditional | Medasonics, Inc. | 04/24/1980SE |
| K800236 | Abco Mercurial SphygmomanometerDXQ · Traditional | Abco Dealers, Inc. | 02/22/1980SE |
| K792355 | Aneroid SphymomanometerDXQ · Traditional | Abco Dealers, Inc. | 12/05/1979SE |
| K792108 | Conphar Blood Pressure CuffsDXQ · Traditional | Conphar, Inc. | 12/04/1979SE |
| K791875 | Parke-Davis Total Hip ProsthesisDXQ · Traditional | Warner-Lambert Co. | 10/04/1979SE |
| K790810 | Disposa-CufDXQ · Traditional | Crest Medical Equipment | 05/25/1979SE |
| K781671 | Blood Pressure Cuff CoverDXQ · Traditional | David Cott Co. | 11/16/1978SE |
| K780715 | Aneroid Type Blood Pressure KitDXQ · Traditional | Mars Metal Co., Ltd. | 07/17/1978SE |
| K771501 | Aneroid SphygmometerDXQ · Traditional | Swartz Medical Equipment | 08/30/1977SE |
| K760655 | Aneroid SphygmomanometerDXQ · Traditional | Abco Dealers, Inc. | 10/05/1976SE |
| K760157 | SphygmomanometerDXQ · Traditional | Eyvirco | 07/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0847-2026 Class II | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product…Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult… | Baxter Healthcare Corporation | 10/28/2025Open, Classified |
| Z-1568-2025 Class II | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | Baxter Healthcare Corporation | 03/21/2025Open, Classified |
| Z-1567-2025 Class II | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as:…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | Baxter Healthcare Corporation | 03/21/2025Open, Classified |
| Z-1566-2025 Class II | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | Baxter Healthcare Corporation | 03/21/2025Open, Classified |
| Z-1564-2025 Class II | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | Baxter Healthcare Corporation | 03/21/2025Open, Classified |
| Z-1562-2025 Class II | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | Baxter Healthcare Corporation | 03/21/2025Open, Classified |
| Z-2027-2024 Class II | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B…Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | GE Medical Systems Information Technologies… | 04/09/2024Open, Classified |
| Z-1270-2022 Class II | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891Due to a potential failed sterilization process. | Volcano Corp | 05/16/2022Terminated |
| Z-1835-2020 Class II | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI:…Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring… | ICU Medical, Inc. | 07/12/2019Terminated |
| Z-2277-2019 Class II | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box…Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was… | Suntech Medical, Inc. | 06/03/2019Terminated |
| Z-1775-2018 Class II | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part…When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the… | ICU Medical, Inc. | 01/05/2018Terminated |
| Z-2581-2011 | Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare…BP cuffs may not properly inflate due to a leak | GE Healthcare, LLC | 04/26/2011Terminated |