DXQ — Blood Pressure Cuff Class II
FDA product code DXQ covers "Blood Pressure Cuff", a Class II medical device regulated under 21 CFR 870.1120. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K254287 | medline industries | Medline Reusable Blood Pressure Cuff | June 22, 2026 |
| K260747 | nihon kohden corporation | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | May 6, 2026 |
| 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 |