FDA applicant
Gemss Healthcare CO., LTD.
FDA records 3 decisions for Gemss Healthcare CO., LTD. (Paju-Si, KR) from 2023 to 2026: 3 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 152 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 Gemss Healthcare CO., LTD.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Gemss Healthcare 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) ReportOther applicant names beginning “Gemss”
FDA records each applicant name separately; these may or may not be the same firm.