FDA applicant
Kj Meditech Co., Ltd.
FDA records 13 decisions for Kj Meditech Co., Ltd. (Fullerton, CA) from 2006 to 2022: 13 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and DZB (Headgear, Extraoral, Orthodontic). Since 2016 its 510(k)s took a median of 474 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Kj Meditech”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kj Meditech Co., Ltd.’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 2007.
Planning a device like Kj Meditech Co., Ltd.’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