Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotrine Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
308 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915060 | ASTECH HOME PEAK FLOW METER | Biotrine Corp. | 1992-09-11 | 308 | 0 |
| K883704 | MULTIICHALLENGE NEBULIZER SYSTEM | Biotrine Corp. | 1988-11-28 | 90 | 0 |
| K863134 | MULTISPIRO SA/100 | Biotrine Corp. | 1986-12-15 | 122 | 0 |
| K844226 | B-1000 | Biotrine Corp. | 1984-11-20 | 19 | 0 |
| K813414 | PEAK FLOW MONITOR | Biotrine Corp. | 1981-12-31 | 24 | 0 |
| K812825 | FLO-COR I | Biotrine Corp. | 1981-10-26 | 18 | 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