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
49–72 of 199
Cleared Apr 02, 2015
Disposable Blood Pressure Cuff Guard
K150227
Pinhu Sama Medical Packing Co., Ltd.
Cardiovascular · 59d
Cleared Sep 19, 2014
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998
Pinghu Sama Medical Packing Co., Ltd.
Cardiovascular · 58d
Cleared Sep 02, 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874
Shanghai Goahui Rubber and Plastic Company
Cardiovascular · 151d
Cleared Jul 02, 2014
SPHYGMOMANOMETER
K141392
Suzhou JJ Meter Co., Ltd.
Cardiovascular · 36d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Oct 17, 2013
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942
Legacy Medical, Inc.
Cardiovascular · 196d
Cleared Apr 09, 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996
Ge Medical Systems Information Technologies, Inc.
Cardiovascular · 104d
Cleared Nov 05, 2012
FLEXIPORT ECOCUFF
K122058
Welch Allyn, Inc.
Cardiovascular · 115d
Cleared Oct 03, 2012
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125
Ge Medical Systems Information Technologies, Inc.
Cardiovascular · 260d
Cleared Sep 24, 2012
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259
Hangzhou Reli-On Co., Ltd.
Cardiovascular · 59d
Cleared May 04, 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364
Unimed Medical Supplies, Inc.
Cardiovascular · 88d
Cleared Nov 22, 2011
UNIMED BLOOD PRESSURE CUFF
K112544
Unimed Medical Supplies, Inc.
Cardiovascular · 82d
Cleared Jun 08, 2011
ERKA. PERFECT-ANEROID
K103637
Erka Kallmeyer Medizintechnik GmbH
Cardiovascular · 177d
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 Jun 09, 2006
AS101, BLOOD PRESSURE CUFF
K060871
Wenzhou Longwan Medical Instrument Company
Cardiovascular · 71d
Cleared Feb 03, 2006
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
K053006
Rossmax Internationl , Ltd.
Cardiovascular · 100d
Cleared Sep 09, 2005
ALL PURPOSE CUFF, MODEL 222APC
K051904
Suntech Medical, Inc.
Cardiovascular · 58d
Cleared Aug 05, 2005
TRICOT BLOOD PRESSURE CUFF
K051539
Ya Horng Electronic Co., Ltd.
Cardiovascular · 56d
Cleared Jun 20, 2005
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
K051021
Shanghai Lord International Trade Co., Ltd.
Cardiovascular · 59d
Cleared Feb 22, 2005
MULTIPLE, MODEL KTJ-50
K043444
Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
Cardiovascular · 70d
Cleared Jan 13, 2005
ANEROID SPHYGMOMANOMETER, MODEL BK2002
K043286
Wenzhou Bokang Instrument Co.,Ltd
Cardiovascular · 48d
Cleared Aug 06, 2004
POLYURETHANE BLOOD PRESSURE CUFFS
K041689
D. E. Hokanson, Inc.
Cardiovascular · 45d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286
Ethox Corp.
Cardiovascular · 38d