FDA applicant
Inspira Technologies Oxy B.H.N., Ltd.
FDA records 1 decision for Inspira Technologies Oxy B.H.N., Ltd. (Ra’Anana, IL) in 2024: 1 510(k) clearance. All are in product code DWA (Control, Pump Speed, Cardiopulmonary Bypass). Its devices cite 1 predicate, 0 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 Inspira Technologies Oxy B.H.N., 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 2024.
Planning a device like Inspira Technologies Oxy B.H.N., 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