FDA applicant
Ketronic, Inc.
FDA records 10 decisions for Ketronic, Inc. (The Netherlands, NL) from 1984 to 1985: 10 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and ISD (Exerciser, Measuring). 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 Ketronic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ketronic, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ketronic, 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