K251637 is an FDA 510(k) clearance for the Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 27, 2025, 90 days after receiving the submission on May 29, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K251637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | August 27, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL - Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |