DXQ · Blood Pressure Cuff
Cardiovascular · 21 CFR 870.1120 · Class 2
Overview
| Product Code | DXQ |
|---|---|
| Device Name | Blood Pressure Cuff |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 197)
Showing 20 most recent of 197 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253089 | 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) | Shenzhen Best Electronics Co., Ltd. | Feb 13, 2026 | SESE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | Jan 9, 2026 | SESE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | Dec 16, 2025 | SESE |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | Sep 3, 2025 | SESE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. | Jul 15, 2025 | SESE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | Oct 31, 2024 | SESE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | Mar 20, 2024 | SESE |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | Dec 21, 2023 | SESE |
| K232772 | 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) | Shenzhen Plinma Technology Co. , Ltd. | Nov 29, 2023 | SESE |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | Aug 30, 2023 | SESE |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | Jun 28, 2023 | SESE |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | Mar 14, 2023 | SESE |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | Cardicare Company, Ltd. | Nov 28, 2022 | SESE |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | Nov 21, 2022 | SESE |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 | Zhejiang Lude Technology Development Co., Ltd. | Oct 13, 2022 | SESE |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 | Wenzhou Xikang Medical Instruments Co., Ltd. | May 18, 2022 | SESE |
| K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | Oct 19, 2021 | SESE |
| K211747 | Reusable NIBP Cuff | Shenzhen Coreray Technology Co., Ltd. | Sep 23, 2021 | SESE |
| K203620 | Aneroid Sphygmomanometer | Wuxi Exanovo Medical Instrument Co., Ltd. | Mar 23, 2021 | SESE |
| K203652 | 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 | Jkh USA, LLC | Jan 6, 2021 | SESE |
Top Applicants
- Rudolf Riester GmbH & Co. KG — 8 clearances
- Conphar, Inc. — 6 clearances
- Abco Dealers, Inc. — 5 clearances
- Pymah Corp. — 5 clearances
- Ethox Corp. — 4 clearances
