510(k) Report

FDA applicant

Ics Medical Corp.

Schaumburg, IL12 decisions1987–20030 recalls

FDA records 12 decisions for Ics Medical Corp. (Schaumburg, IL) from 1987 to 2003: 12 510(k) clearances. Most are in product codes KHH (Stimulator, Caloric-Air) and GWN (Nystagmograph). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ics Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

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

FDA decisions per year

No FDA decision for Ics Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ics Medical Corp.’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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