FDA applicant
American Healthcare Corp.
FDA records 17 decisions for American Healthcare Corp. (South Plainfield, NJ) from 1986 to 2005: 17 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and EYN (Tray, Irrigation, Sterile). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “American Healthcare, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Healthcare Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Healthcare Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Healthcare Corp.’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