Flight Medical Innovations , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Flight Medical Innovations , Ltd.” (first 2011, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 439 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 119 |
| 2013 | 0 | — |
| 2014 | 1 | 439 |
| 2015 | 0 | — |
| 2016 | 1 | 525 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 791 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Flight Medical Innovations , Ltd. took a median 791 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 266 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Flight Medical Innovations , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223120 | Ventoux VC2; Ventoux VC3 | CBK | 2024-12-02 | 791 |
| K143035 | Flight 60 Ventilator | CBK | 2016-03-30 | 525 |
| K130171 | FLIGHT 60 VENTILATOR | CBK | 2014-04-08 | 439 |
| K120726 | FLIGHT 60 VENTILATOR | CBK | 2012-07-06 | 119 |
| K111683 | FLIGHT 60 VENTILATOR | CBK | 2011-10-31 | 138 |
Recalls
openFDA lists no recalls under a recalling firm named Flight Medical Innovations , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Flight Medical , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Flight Medical Innovations , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Flight Medical Innovations , Ltd.” (first 2011, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Flight Medical Innovations , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Flight Medical Innovations , Ltd. is 439 days.
Which FDA product codes appear under Flight Medical Innovations , Ltd.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 5).
Next steps
- See all 5 Flight Medical Innovations , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Flight Medical Innovations , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.