Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biofire Diagnostics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
80 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131930 | JBAIDS ANTHRAX DETECTION KIT | Biofire Diagnostics, Inc. | 2013-08-05 | 39 | 1 |
| K131729 | JBAIDS PLAGUE DETECTION KIT | Biofire Diagnostics, Inc. | 2013-07-31 | 49 | 0 |
| K131936 | JBAIDS TULAREMIA DETECTION KIT | Biofire Diagnostics, Inc. | 2013-07-31 | 34 | 0 |
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | Biofire Diagnostics, Inc. | 2013-06-21 | 80 | 3 |
| K123620 | FILMARRAY RESPIRATORY PANEL (RP) | Biofire Diagnostics, Inc. | 2013-02-11 | 80 | 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