FDA applicant
Dk Medical Systems Co., Ltd.
FDA records 3 decisions for Dk Medical Systems Co., Ltd. (Pyeongtaek-Si, KR) from 2025 to 2026: 3 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Dk Medical Systems Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Dk Medical Systems 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