Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Donnevie Medical Technology (Shanghai) Co. , Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 | 90 | 0 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Tha | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 | 225 | 0 |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2023-08-04 | 84 | 0 |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with H | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2022-06-16 | 316 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda