DXQ
- Product code
- DXQ
- Device name
- Blood Pressure Cuff
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1120
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 199
FDA classification 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.
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254287 | 2026-06-22 | Medline Industries, LP | Medline Reusable Blood Pressure Cuff | |
| K260747 | 2026-05-06 | Nihon Kohden Corporation | YP-710T Series NIBP Cuff;YP-840T Series Disposable C | |
| K253089 | 2026-02-13 | Shenzhen Best Electronics Co., Ltd. | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-5 | |
| K253964 | 2026-01-09 | Unimed Medical Supplies, Inc. | Disposable Neonatal NIBP Cuff (U1681S-C51N) | |
| K251745 | 2025-12-16 | Baxter Healthcare Corporation | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPor | |
| K250765 | 2025-09-03 | Avita Corporation | AViTA Arm Type Blood Pressure Monitor Cuff | |
| K251045 | 2025-07-15 | Unimed Medical Supplies, Inc. | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposa | |
| K242623 | 2024-10-31 | Shenzhen Medke Technology Co., Ltd. | Disposable Blood Pressure cuff; Reusable Blood Press | |
| K240165 | 2024-03-20 | Wenzhou Longwan Medical Device Factory | Aneroid Sphygmomanometer with Stethoscope; Aneroid S | FDA |
| K233276 | 2023-12-21 | Suzhou Minhua Medical Apparatus Suppli | Reusable Blood Pressure Cuff | |
| K232772 | 2023-11-29 | Shenzhen Plinma Technology Co. , Ltd. | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,120 |
Official FDA classification page: DXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).