FDA applicant
Gaymar Industries, Inc.
FDA records 27 decisions for Gaymar Industries, Inc. (Orchard Park, NY) from 1976 to 2011: 27 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and ILO (Pack, Hot Or Cold, Water Circulating). Its devices cite 7 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gaymar Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
2in 2017
Class I Class II/III not classified
Planning a device like Gaymar Industries, 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