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
49–72 of 199
Cleared Jul 01, 1994
HAND ANEROID SPHYGMOMANOMETER
K940493
Welch Allyn, Inc.
Cardiovascular · 149d
Cleared Jul 25, 1991
BLOOD PRESSURE CUFFS
K912638
Vital Signs, Inc.
Cardiovascular · 41d
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 Jun 20, 1988
C-FLO SUCTION TUBE
K882121
Concept, Inc.
Cardiovascular · 32d
Cleared Feb 02, 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939
Kirschner Medical Corp.
Cardiovascular · 62d
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 May 25, 1982
ONE HAND ANEROID SPHYGMOMANOMETER
K821232
Abco Dealers, Inc.
Cardiovascular · 27d
Cleared Mar 15, 1982
RELIEVED REINFORCED CUP
K820539
Biomet, Inc.
Cardiovascular · 13d
Cleared Jan 22, 1982
CONPHAR PALM ANEROID SPHYGMOMANOMETER
K813302
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
CONPHAR, WALL ANEROID SPHYGMOMANOMETER
K813303
Conphar, Inc.
Cardiovascular · 60d
Cleared Dec 29, 1981
THIGH CUFF: X-LARGE CUFF
K813323
Abco Dealers, Inc.
Cardiovascular · 35d
Cleared Nov 06, 1981
TRONZO HIP
K812946
Biomet, Inc.
Cardiovascular · 17d
Cleared Jun 09, 1980
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER
K801186
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
CONPHAR DESK TOP MERCURY SPHYGMOMAN
K801188
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 04, 1980
CONPHAR WALL MODEL MERCURY SPHYGMOMAN.
K801182
Conphar, Inc.
Cardiovascular · 19d
Cleared Feb 22, 1980
ABCO MERCURIAL SPHYGMOMANOMETER
K800236
Abco Dealers, Inc.
Cardiovascular · 17d
Cleared Dec 05, 1979
ANEROID SPHYMOMANOMETER
K792355
Abco Dealers, Inc.
Cardiovascular · 14d
Cleared Dec 04, 1979
CONPHAR BLOOD PRESSURE CUFFS
K792108
Conphar, Inc.
Cardiovascular · 40d