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 198)
Showing 20 most recent of 198 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | May 6, 2026 | SESE |
| 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 |
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
