FDA applicant
Atcor Medical
FDA records 5 decisions for Atcor Medical (Washington, D.C., DC) from 2002 to 2023: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DSK (Computer, Blood-Pressure). Its devices cite 14 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Atcor Medical Pty, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Atcor Medical’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Atcor Medical’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