FDA applicant
Fine Advanced Compound Co., Ltd.
FDA records 1 decision for Fine Advanced Compound Co., Ltd. (Pyeongtaek, KR) in 2019: 1 510(k) clearance. All are in product code EIH (Powder, Porcelain). Its devices cite 1 predicate, 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 Fine Advanced Compound 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 2019.
Planning a device like Fine Advanced Compound 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 “Fine”
FDA records each applicant name separately; these may or may not be the same firm.