K252805 is an FDA 510(k) clearance for the YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on February 17, 2026, 167 days after receiving the submission on September 3, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K252805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2025 |
| Decision Date | February 17, 2026 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |