K253089 is an FDA 510(k) clearance for the 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). This device is classified as a Blood Pressure Cuff (Class II - Special Controls, product code DXQ).
Submitted by Shenzhen Best Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 13, 2026, 143 days after receiving the submission on September 23, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1120. 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) Number | K253089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2025 |
| Decision Date | February 13, 2026 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXQ - Blood Pressure Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| 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. |