Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wuhan Dymex Healthcare 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) |
|---|---|---|---|---|---|
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | 2022-06-10 | 106 | 0 |
| K211809 | Surgical Gown | Wuhan Dymex Healthcare Co., Ltd. | 2021-10-18 | 129 | 0 |
| K210433 | Surgical Face Mask (Ear loops and Tie-on) | Wuhan Dymex Healthcare Co., Ltd. | 2021-06-07 | 115 | 0 |
| K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | 2019-05-27 | 257 | 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