FDA applicant
Epic Systems, Inc.
FDA records 4 decisions for Epic Systems, Inc. (Darby, MT) from 1991 to 2026: 4 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and QNL (Medium-Term Adjunctive Predictive…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Epic Systems Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Epic Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Epic Systems, Inc.’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.