FDA applicant
Beijing Zksk Technology Co., Ltd.
FDA records 6 decisions for Beijing Zksk Technology Co., Ltd. (Beijing, CN) from 2022 to 2025: 6 510(k) clearances. Most are in product codes KGE (Forceps, Biopsy, Electric) and PKL (Hemostatic Metal Clip For The Gi Tract). Since 2016 its 510(k)s took a median of 248 days from receipt to decision, against 230 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 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 Beijing Zksk Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Beijing Zksk Technology 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