FDA applicant
Air Safety, Ltd.
FDA records 4 decisions for Air Safety, Ltd. (Mccordsville, IN) from 2004 to 2005: 4 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and BZG (Spirometer, Diagnostic). Its devices cite 8 predicates, 1 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 Air Safety, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Air Safety, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Air Safety, 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) Report