Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Qingdao Bright Moon Biomedical Materials Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 | 162 | 0 |
| K220673 | Sterile Silver Alginate Wound Dressing | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2023-03-16 | 374 | 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