DXQ · Class II · 21 CFR 870.1120

FDA Product Code DXQ: Blood Pressure Cuff

Blood pressure measurement depends on accurate, well-fitting cuffs. FDA product code DXQ covers blood pressure cuffs used with sphygmomanometers for indirect blood pressure measurement.

These inflatable cuffs are wrapped around the arm or thigh and inflated to occlude the brachial or popliteal artery, with controlled deflation allowing assessment of systolic and diastolic pressure. Correct cuff sizing is critical to measurement accuracy.

DXQ devices are Class II medical devices, regulated under 21 CFR 870.1120 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Rudolf Riester GmbH & Co. KG, Conphar, Inc. and Abco Dealers, Inc..

199
Total
199
Cleared
100d
Avg days
1976
Since
199 devices
25–48 of 199
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular · 90d
Cleared Sep 17, 2019
Reusable NIBP Cuff
K191253
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular · 131d
Cleared Jun 18, 2019
Aneroid Type Blood Pressure Kit
K191209
Dongguan Mars Medical Products Co., Ltd.
Cardiovascular · 43d
Cleared May 22, 2019
RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
K190902
Wenzhou Renhua Instruments Co., Ltd.
Cardiovascular · 44d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433
Shenzhen Caremed Medical Technology Co., Ltd.
Cardiovascular · 102d
Cleared Aug 21, 2018
Reusable NIBP Cuff
K173197
Orantech, Inc.
Cardiovascular · 323d
Cleared Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
K173869
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular · 225d
Cleared May 30, 2018
ANEROID SPHYGMOMANOMETER
K173246
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 236d
Cleared Mar 08, 2018
Accutension Smartphone Auscultatory Blood
K180335
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 30d
Cleared Dec 19, 2017
Reusable Blood Pressure Cuff
K171889
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Cardiovascular · 176d
Cleared Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044
Ningbo Albert Novosino Co., Ltd.
Cardiovascular · 53d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular · 277d
Cleared Jun 13, 2016
Medline Singe Patient Use Blood Pressure Cuff
K161035
Medline Industries, Inc.
Cardiovascular · 61d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006
Icu Medical, Inc.
Cardiovascular · 289d
Cleared Apr 14, 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
K153251
Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.
Cardiovascular · 156d
Cleared Dec 17, 2015
Bpump Blood Pressure Cuff
K151810
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 168d
Cleared Oct 29, 2015
Disposable Blood Pressure Cuff
K152465
Shenzhen Vistar Medical Supplies Co., Ltd.
Cardiovascular · 59d
Cleared Oct 29, 2015
Reusable Blood Pressure Cuff
K152468
Shenzhen Vistar Medical Supplies Co., Ltd.
Cardiovascular · 59d
Cleared Oct 27, 2015
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363
Philips Medical Systems
Cardiovascular · 68d
Cleared Oct 27, 2015
ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
K152801
Statcorp Medical
Cardiovascular · 29d
Cleared Jun 30, 2015
Aneroid Sphygmomanometer
K151246
Jiaxing Zhongfa Medical Products Co., Ltd.
Cardiovascular · 50d
Cleared Jun 30, 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
K151290
Xuzhou Maicuff Technology Co., Ltd.
Cardiovascular · 46d
Cleared May 15, 2015
Minhua Disposable Blood Pressure Cuff
K143728
Suzhou Minhua Medical Apparatus
Cardiovascular · 137d
Cleared Apr 14, 2015
Fast Sphyg by Koven
K143332
Koven Technology, Inc.
Cardiovascular · 145d