FDA applicant
Flight Medical Innovations, Ltd.
FDA records 5 decisions for Flight Medical Innovations, Ltd. (Chalotte, NC) from 2011 to 2024: 5 510(k) clearances. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Flight Medical Innovations, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Flight Medical Innovations, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Flight”
FDA records each applicant name separately; these may or may not be the same firm.