510(k) Report

FDA applicant

Clinical Computer Systems, Inc.

Elgin, IL1 decision2012–20120 recalls

FDA records 1 decision for Clinical Computer Systems, Inc. (Elgin, IL) in 2012: 1 510(k) clearance. All are in product code HGM (System, Monitoring, Perinatal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Clinical Computer Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Clinical Computer Systems, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clinical Computer Systems, 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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