K251691 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2025, 182 days after receiving the submission on June 2, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K251691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2025 |
| Decision Date | December 01, 2025 |
| Days to Decision | 182 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 |