510(k) Report

FDA applicant

Du Pont Critical Care

Waukegan, IL1 decision1989–19890 recalls

FDA records 1 decision for Du Pont Critical Care (Waukegan, IL) in 1989: 1 510(k) clearance. All are in product code KDL (Set, Perfusion, Kidney, Disposable). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Du Pont Critical Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Du Pont Critical Care since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Du Pont Critical Care 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?

  • KDLSet, Perfusion, Kidney, Disposable1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K883782Belzer UW-CSSDu Pont Critical Care · 19891cites it

What has FDA decided for it lately?

  • K883782Belzer UW-CSSDu Pont Critical Care · 1989

The one decision as Du Pont Critical Care →