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
Cleared
Mar 25, 2020
Disposable NIBP Cuff
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular
90d
Cleared
Sep 17, 2019
Reusable NIBP Cuff
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular
131d
Cleared
Jun 18, 2019
Aneroid Type Blood Pressure Kit
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
Wenzhou Renhua Instruments Co., Ltd.
Cardiovascular
44d
Cleared
Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
Shenzhen Caremed Medical Technology Co., Ltd.
Cardiovascular
102d
Cleared
Aug 21, 2018
Reusable NIBP Cuff
Orantech, Inc.
Cardiovascular
323d
Cleared
Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular
225d
Cleared
May 30, 2018
ANEROID SPHYGMOMANOMETER
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular
236d
Cleared
Mar 08, 2018
Accutension Smartphone Auscultatory Blood
Shanghai Hulu Devices Co., Ltd.
Cardiovascular
30d
Cleared
Dec 19, 2017
Reusable Blood Pressure Cuff
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Cardiovascular
176d
Cleared
Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
Ningbo Albert Novosino Co., Ltd.
Cardiovascular
53d
Cleared
Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
Shenzhen Med-Link Electronics Tech Co., Ltd.
Cardiovascular
277d
Cleared
Jun 13, 2016
Medline Singe Patient Use Blood Pressure Cuff
Medline Industries, Inc.
Cardiovascular
61d
Cleared
May 05, 2016
Cogent Hemodynamic Monitoring System
Icu Medical, Inc.
Cardiovascular
289d
Cleared
Apr 14, 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.
Cardiovascular
156d
Cleared
Dec 17, 2015
Bpump Blood Pressure Cuff
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular
168d
Cleared
Oct 29, 2015
Disposable Blood Pressure Cuff
Shenzhen Vistar Medical Supplies Co., Ltd.
Cardiovascular
59d
Cleared
Oct 29, 2015
Reusable Blood Pressure Cuff
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
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
Statcorp Medical
Cardiovascular
29d
Cleared
Jun 30, 2015
Aneroid Sphygmomanometer
Jiaxing Zhongfa Medical Products Co., Ltd.
Cardiovascular
50d
Cleared
Jun 30, 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
Xuzhou Maicuff Technology Co., Ltd.
Cardiovascular
46d
Cleared
May 15, 2015
Minhua Disposable Blood Pressure Cuff
Suzhou Minhua Medical Apparatus
Cardiovascular
137d
Cleared
Apr 14, 2015
Fast Sphyg by Koven
Koven Technology, Inc.
Cardiovascular
145d