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 Howmedica Corp., Hewlett-Packard Co. and Shenzhen Changke Connect Electronics Co., Ltd..

198
Total
198
Cleared
99d
Avg days
1976
Since
198 devices
25–48 of 198
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 Mar 05, 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244
Medline Industries, Inc.
Cardiovascular · 307d
Cleared Dec 27, 1990
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147
Hewlett-Packard Co.
Cardiovascular · 42d
Cleared Dec 20, 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101
Hewlett-Packard Co.
Cardiovascular · 37d
Cleared Jul 31, 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252
Hewlett-Packard Co.
Cardiovascular · 137d
Cleared Jul 30, 1985
POROCOAT SCHATZKER II ACETABULUM
K852193
Depuy, Inc.
Cardiovascular · 71d
Cleared Jul 29, 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964
Howmedica Corp.
Cardiovascular · 17d
Cleared Jul 19, 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565
Howmedica Corp.
Cardiovascular · 94d
Cleared Mar 29, 1983
FREEMAN ACETABULAR CUP
K823843
Depuy, Inc.
Cardiovascular · 98d
Cleared Jan 28, 1983
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097
Howmedica Corp.
Cardiovascular · 17d
Cleared Mar 15, 1982
RELIEVED REINFORCED CUP
K820539
Biomet, Inc.
Cardiovascular · 13d
Cleared Nov 06, 1981
TRONZO HIP
K812946
Biomet, Inc.
Cardiovascular · 17d