FDA applicant
Epic Medical Pte., Ltd.
FDA records 22 decisions for Epic Medical Pte., Ltd. (Singapore, SG) from 2016 to 2026: 22 510(k) clearances. Most are in product codes ONB (Closed Antineoplastic And Hazardous Drug…) and KPE (Container, I.V.). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 14 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 Epic Medical Pte., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Epic Medical Pte., 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 “Epic”
FDA records each applicant name separately; these may or may not be the same firm.