FDA applicant
Gke-GmbH
FDA records 1 decision for Gke-GmbH (Waldems, DE) in 2017: 1 510(k) clearance. All are in product code FRC (Indicator, Biological Sterilization Process). 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 Gke-GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2017high 1 (2017) · low 0 (2018)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Gke-GmbH’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