Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bh Medical Products Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019-09-10 | 195 | 0 |
| K172280 | BH Sterilization Pouch | Bh Medical Products Co., Ltd. | 2018-08-03 | 371 | 0 |
| K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015-06-22 | 630 | 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