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
145–168 of 199
Cleared Jul 22, 1991
BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
K912007
Tecnadyne Scientific, Inc.
Cardiovascular · 77d
Cleared May 08, 1991
INFLATE-A-CUFF #7014
K910903
Pa Medical Corp.
Cardiovascular · 64d
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 Oct 19, 1990
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379
Pymah Corp.
Cardiovascular · 81d
Cleared Jul 31, 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252
Hewlett-Packard Co.
Cardiovascular · 137d
Cleared Jun 29, 1990
CUFF, BLOOD PRESSURE
K902132
Buffalo Medical Specialties Mfg., Inc.
Cardiovascular · 50d
Cleared May 09, 1990
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
K901506
Yamasu Co. , Ltd.
Cardiovascular · 40d
Cleared Mar 06, 1990
BLOOD PRESSURE CUFF
K896986
Latex Medical Devices, Inc.
Cardiovascular · 85d
Cleared Jan 19, 1990
DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
K896788
Advanced Medical Instruments, Inc.
Cardiovascular · 46d
Cleared Feb 10, 1989
SURGI-CUF STERILE/NON-STERILE DISPOSABLE
K883977
Ethox Corp.
Cardiovascular · 143d
Cleared Jan 13, 1989
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421
Pymah Corp.
Cardiovascular · 85d
Cleared Oct 14, 1988
BLOOD PRESSURE CUFF
K881799
Biomedical Dynamics, Inc.
Cardiovascular · 170d
Cleared Jun 20, 1988
C-FLO SUCTION TUBE
K882121
Concept, Inc.
Cardiovascular · 32d
Cleared Mar 22, 1988
BLOOD PRESSURE SLEEVE W/TUBING
K874233
Devcom, Inc.
Cardiovascular · 159d
Cleared Feb 02, 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939
Kirschner Medical Corp.
Cardiovascular · 62d
Cleared Jul 29, 1987
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER
K872144
Vestra-Subco, Inc.
Cardiovascular · 55d
Cleared Jun 20, 1986
MEDNOVA BLOOD PRESSURE CUFF
K854813
Mednova Corp.
Cardiovascular · 199d
Cleared Mar 26, 1986
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K854023
Philips Park
Cardiovascular · 177d
Cleared Dec 17, 1985
THE CALIFORNIA SPLINT
K854752
Intl. Medication Systems, Ltd.
Cardiovascular · 21d
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 Apr 04, 1985
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
K844988
Ethox Corp.
Cardiovascular · 99d