FDA applicant
Accucore, Inc.
FDA records 9 decisions for Accucore, Inc. (Santa Ana, CA) from 1987 to 1995: 9 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DXH (Transmitters And Receivers…). 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 Accucore, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Accucore, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Accucore, 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) Report