Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flight Medical Innovations , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
439 daysmedian FDA review time
791 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 | 791 | 0 |
| K143035 | Flight 60 Ventilator | Flight Medical Innovations , Ltd. | 2016-03-30 | 525 | 0 |
| K130171 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2014-04-08 | 439 | 0 |
| K120726 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2012-07-06 | 119 | 0 |
| K111683 | FLIGHT 60 VENTILATOR | Flight Medical Innovations , Ltd. | 2011-10-31 | 138 | 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