FDA applicant
Imedicom Co., Ltd.
FDA records 7 decisions for Imedicom Co., Ltd. (Gunpo-Si, KR) from 2014 to 2019: 7 510(k) clearances. Most are in product codes HRX (Arthroscope) and BSO (Catheter, Conduction, Anesthetic). Since 2016 its 510(k)s took a median of 308 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Imedicom”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Imedicom Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Imedicom 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