510(k) Report

FDA applicant

Icu Datasystems, Inc.

Gainesville, FL1 decision2003–20030 recalls

FDA records 1 decision for Icu Datasystems, Inc. (Gainesville, FL) in 2003: 1 510(k) clearance. All are in product code MWI (Monitor, Physiological, Patient (Without…). 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 Icu Datasystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icu Datasystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033283Centra View Device Link SystemIcu Datasystems, Inc. · 20032cite it

What has FDA decided for it lately?

  • K033283Centra View Device Link SystemIcu Datasystems, Inc. · 2003

The one decision as Icu Datasystems, Inc. →