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 Conphar, Inc., Abco Dealers, Inc. and Welch Allyn, Inc..

199
Total
199
Cleared
100d
Avg days
1976
Since
199 devices
25–48 of 199
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 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 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 Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Nov 05, 2012
FLEXIPORT ECOCUFF
K122058
Welch Allyn, Inc.
Cardiovascular · 115d
Cleared Mar 05, 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244
Medline Industries, Inc.
Cardiovascular · 307d
Cleared Dec 18, 2007
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060
Welch Allyn, Inc.
Cardiovascular · 347d
Cleared Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356
Card Guard Scientific Survival , Ltd.
Cardiovascular · 101d
Cleared Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482
Ge Medical Systems Information Technologies
Cardiovascular · 15d
Cleared Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455
Welch Allyn, Inc.
Cardiovascular · 16d
Cleared Feb 25, 2000
CLEEN-ABLE
K994044
Vital Signs, Inc.
Cardiovascular · 88d
Cleared Sep 01, 1999
CUFF-ABLE PLUS
K990412
Vital Signs, Inc.
Cardiovascular · 203d
Cleared Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525
Deroyal Industries, Inc.
Cardiovascular · 78d
Cleared May 18, 1998
CRITIKON SOFT BLOOD PRESSURE CUFF
K974080
Johnson & Johnson Medical, Inc.
Cardiovascular · 201d
Cleared Jan 27, 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655
American Diagnostic Corp.
Cardiovascular · 203d
Cleared Sep 28, 1995
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952
Deroyal Industries, Inc.
Cardiovascular · 37d