510(k) Report

FDA applicant

Impoex International, Ltd.

Little River, SC1 decision2002–20020 recalls

FDA records 1 decision for Impoex International, Ltd. (Little River, SC) in 2002: 1 510(k) clearance. All are in product code BTM (Ventilator, Emergency, Manual (Resuscitator)). No recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Impoex International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Impoex International, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Impoex International, Ltd.’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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