510(k) Report

FDA applicant

Flight Medical Innovations, Ltd.

Chalotte, NC5 decisions2011–20240 recalls

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, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

2011: 12012: 12014: 12016: 12024: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Flight Medical Innovations, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Flight”

FDA records each applicant name separately; these may or may not be the same firm.