510(k) Report

FDA applicant

Compumed, Inc.

Mchenry, IL6 decisions1977–19990 recalls

FDA records 6 decisions for Compumed, Inc. (Mchenry, IL) from 1977 to 1999: 6 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and DSI (Detector And Alarm, Arrhythmia). No recall is linked to its devices.

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 Compumed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Compumed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Compumed, Inc.’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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