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 Unimed Medical Supplies, Inc..

198
Total
198
Cleared
99d
Avg days
1976
Since
Declining activity - 7 submissions in the last 2 years vs 9 in the prior period
Consistent review times: 109d avg (recent)

FDA 510(k) Cleared Blood Pressure Cuff Devices (Product Code DXQ)

198 devices
1–24 of 198
Cleared May 06, 2026
YP-710T Series NIBP Cuff
K260747
Nihon Kohden Corporation
Cardiovascular · 61d
Cleared Feb 13, 2026
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
K253089
Shenzhen Best Electronics Co., Ltd.
Cardiovascular · 143d
Cleared Jan 09, 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964
Unimed Medical Supplies, Inc.
Cardiovascular · 29d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Sep 03, 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765
Avita Corporation
Cardiovascular · 174d
Cleared Jul 15, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045
Unimed Medical Supplies, Inc.
Cardiovascular · 103d
Cleared Oct 31, 2024
Disposable Blood Pressure cuff
K242623
Shenzhen Medke Technology Co., Ltd.
Cardiovascular · 58d
Cleared Mar 20, 2024
Aneroid Sphygmomanometer with Stethoscope
K240165
Wenzhou Longwan Medical Device Factory
Cardiovascular · 58d
Cleared Dec 21, 2023
Reusable Blood Pressure Cuff
K233276
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Cardiovascular · 83d
Cleared Nov 29, 2023
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
K232772
Shenzhen Plinma Technology Co. , Ltd.
Cardiovascular · 79d
Cleared Aug 30, 2023
NIBPCuff
K231961
Shenzhen Sino-K Medical Technology Co.,Ltd
Cardiovascular · 58d
Cleared Jun 28, 2023
Aneroid Sphygmomanometer
K230859
Wenzhou Kangshun Medical Devices Co.,Ltd
Cardiovascular · 91d
Cleared Mar 14, 2023
ONE-CUF
K230145
Ge Medical Systems Information Technologies, Inc.
Cardiovascular · 55d
Cleared Nov 28, 2022
Aneroid Sphygmomanometer
K222652
Cardicare Company, Ltd.
Cardiovascular · 88d
Cleared Nov 21, 2022
Disposable Blood Pressure Cuff
K222420
Wenzhou Xikang Medical Instruments Co., Ltd.
Cardiovascular · 102d
Cleared Oct 13, 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
K221857
Zhejiang Lude Technology Development Co., Ltd.
Cardiovascular · 108d
Cleared May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
K212416
Wenzhou Xikang Medical Instruments Co., Ltd.
Cardiovascular · 288d
Cleared Oct 19, 2021
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084
Shanghai Caremate Medical Device Co., Ltd.
Cardiovascular · 190d
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Mar 23, 2021
Aneroid Sphygmomanometer
K203620
Wuxi Exanovo Medical Instrument Co., Ltd.
Cardiovascular · 102d
Cleared Jan 06, 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
K203652
Jkh USA, LLC
Cardiovascular · 23d
Cleared Jul 02, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259
Little Doctor Electronic (Nantong)Co.,Ltd
Cardiovascular · 219d
Cleared Apr 06, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500
Honsun (Nantong) Co., Ltd.
Cardiovascular · 207d
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629
Shenzhen Changke Connect Electronics Co., Ltd.
Cardiovascular · 90d

About Product Code DXQ - Regulatory Context

510(k) Submission Activity

198 total 510(k) submissions under product code DXQ since 1976, with 198 receiving FDA clearance (average review time: 99 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - DXQ Product Code

FDA review times for DXQ submissions have been consistent, averaging 109 days recently vs 99 days historically.

DXQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →