K250931 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117). 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 August 13, 2025, 138 days after receiving the submission on March 28, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K250931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | August 13, 2025 |
| Days to Decision | 138 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 |