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 Conphar, Inc., Abco Dealers, Inc. and Welch Allyn, Inc..
199
Total
199
Cleared
100d
Avg days
1976
Since
199 devices
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
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
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
Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
Andon Health Co, Ltd.
Cardiovascular
155d
Cleared
Nov 05, 2012
FLEXIPORT ECOCUFF
Welch Allyn, Inc.
Cardiovascular
115d
Cleared
Mar 05, 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
Medline Industries, Inc.
Cardiovascular
307d
Cleared
Dec 18, 2007
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
Welch Allyn, Inc.
Cardiovascular
347d
Cleared
Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
Card Guard Scientific Survival , Ltd.
Cardiovascular
101d
Cleared
Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
Ge Medical Systems Information Technologies
Cardiovascular
15d
Cleared
Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
Welch Allyn, Inc.
Cardiovascular
16d
Cleared
Feb 25, 2000
CLEEN-ABLE
Vital Signs, Inc.
Cardiovascular
88d
Cleared
Sep 01, 1999
CUFF-ABLE PLUS
Vital Signs, Inc.
Cardiovascular
203d
Cleared
Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
Deroyal Industries, Inc.
Cardiovascular
78d
Cleared
May 18, 1998
CRITIKON SOFT BLOOD PRESSURE CUFF
Johnson & Johnson Medical, Inc.
Cardiovascular
201d
Cleared
Jan 27, 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
American Diagnostic Corp.
Cardiovascular
203d
Cleared
Sep 28, 1995
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
Deroyal Industries, Inc.
Cardiovascular
37d