FDA applicant
Acutronic Medical Systems AG
FDA records 12 decisions for Acutronic Medical Systems AG (Jona-Rapper Swril, CH) from 1986 to 2002: 12 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZA (Connector, Airway (Extension)). Its devices cite 3 predicates, 3 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 Acutronic Medical Systems AG’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Acutronic Medical Systems AG since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Acutronic Medical Systems AG’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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