Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermo Biostar, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
217 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032330 | CT OIA | Thermo Biostar, Inc. | 2004-03-02 | 217 | 0 |
| K023947 | GC OIA | Thermo Biostar, Inc. | 2003-04-17 | 141 | 0 |
| K023556 | FLU OIA A/B TEST KIT | Thermo Biostar, Inc. | 2003-03-27 | 155 | 1 |
| K023779 | RSV OIA | Thermo Biostar, Inc. | 2003-01-14 | 63 | 0 |
| K021172 | RSV OIA | Thermo Biostar, Inc. | 2002-09-13 | 154 | 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