FDA applicant
eVent Medical, Ltd.
FDA records 7 decisions for eVent Medical, Ltd. (Galway, IE) from 2002 to 2013: 7 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BTI (Compressor, Air, Portable). Its devices cite 12 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Event Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided eVent Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like eVent Medical, 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