DXQ — Blood Pressure Cuff Class II
Classification Details
- Product Code
- DXQ
- Device Class
- Class II
- Regulation Number
- 870.1120
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253089 | shenzhen best electronics co | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-12 | February 13, 2026 |
| K253964 | unimed medical supplies | Disposable Neonatal NIBP Cuff (U1681S-C51N) | January 9, 2026 |
| K251745 | baxter healthcare corporation | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | December 16, 2025 |
| K250765 | avita corporation | AViTA Arm Type Blood Pressure Monitor Cuff | September 3, 2025 |
| K251045 | unimed medical supplies | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 | July 15, 2025 |
| K242623 | shenzhen medke technology co | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | October 31, 2024 |
| K240165 | wenzhou longwan medical device factory | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | March 20, 2024 |
| K233276 | suzhou minhua medical apparatus supplies co | Reusable Blood Pressure Cuff | December 21, 2023 |
| K232772 | shenzhen plinma technology co. | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 | November 29, 2023 |
| K231961 | shenzhen sino-k medical technology co | NIBPCuff | August 30, 2023 |
| K230859 | wenzhou kangshun medical devices co | Aneroid Sphygmomanometer | June 28, 2023 |
| K230145 | ge medical systems information technologies | ONE-CUF | March 14, 2023 |
| K222652 | cardicare company | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | November 28, 2022 |
| K222420 | wenzhou xikang medical instruments co | Disposable Blood Pressure Cuff | November 21, 2022 |
| K221857 | zhejiang lude technology development co | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-2 | October 13, 2022 |
| K212416 | wenzhou xikang medical instruments co | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressur | May 18, 2022 |
| K211084 | shanghai caremate medical device co | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | October 19, 2021 |
| K211747 | shenzhen coreray technology co | Reusable NIBP Cuff | September 23, 2021 |
| K203620 | wuxi exanovo medical instrument co | Aneroid Sphygmomanometer | March 23, 2021 |
| K203652 | jkh usa | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressu | January 6, 2021 |