FDA applicant
RF Medical Co., Ltd.
FDA records 4 decisions for RF Medical Co., Ltd. (Seoul, KR) from 2018 to 2023: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 181 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 3 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 RF Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like RF Medical 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