Submission Details
| 510(k) Number | K251696 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
Dec 2025
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K251696 is an FDA 510(k) clearance for the Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29), 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 review panel. Regulated under 21 CFR 870.2700.
Device Classification
| Product Code | DQA — Oximeter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
Manufacturer
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