Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BMC Medical Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
215 daysmedian FDA review time
433 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 | 215 | 0 |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | 2025-01-15 | 112 | 0 |
| K213169 | BPAP System | BMC Medical Co., Ltd. | 2022-12-05 | 433 | 0 |
| K211155 | Auto CPAP System | BMC Medical Co., Ltd. | 2022-03-09 | 324 | 0 |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | BMC Medical Co., Ltd. | 2014-04-23 | 210 | 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