FDA applicant
Jk-Holding GmbH
FDA records 6 decisions for Jk-Holding GmbH (Windhagen, DE) from 2015 to 2022: 6 510(k) clearances. All are in product code LEJ (Booth, Sun Tan). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Jk Holding GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jk-Holding GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Jk-Holding 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