K250185 is an FDA 510(k) clearance for the Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Jiangxi Aicare Medical Technology Co., Ltd. (Fuzhou City, CN). The FDA issued a Cleared decision on July 14, 2025, 173 days after receiving the submission on January 22, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K250185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2025 |
| Decision Date | July 14, 2025 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |