510(k) Report

FDA applicant

Frontline Medical

Limerick, IE2 decisions1985–20060 recalls

FDA records 2 decisions for Frontline Medical (Limerick, IE) from 1985 to 2006: 2 510(k) clearances. Most are in product codes KNA (Instrument, Manual, Specialized…) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Frontline Medical Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Frontline Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Frontline Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Frontline Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Frontline Medical’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 “Frontline”

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