510(k) Report

FDA applicant

Gempco, Inc.

Lisle, IL4 decisions1988–19880 recalls

FDA records 4 decisions for Gempco, Inc. (Lisle, IL) in 1988: 4 510(k) clearances. All are in product code FMT (Warmer, Infant Radiant). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Gempco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gempco, Inc.’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