FDA applicant
Gempco, Inc.
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
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.
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