510(k) Report

FDA applicant

Atcor Medical

Washington, D.C., DC5 decisions2002–20230 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Atcor Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12008: 12012: 12023: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Atcor Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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