K241634 is an FDA 510(k) clearance for the Wrist Blood Pressure Monitor (XY-W01A, XY-W01B). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Guangdong Xinyu Electronic and Technology Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on February 11, 2025, 250 days after receiving the submission on June 6, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K241634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2024 |
| Decision Date | February 11, 2025 |
| Days to Decision | 250 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 |