510(k) Report

FDA applicant

The Dupont Merck Pharmaceutical Co.

Wilmington, DE1 decision1996–19961 recall

FDA records 1 decision for The Dupont Merck Pharmaceutical Co. (Wilmington, DE) in 1996: 1 510(k) clearance. All are in product code KDL (Set, Perfusion, Kidney, Disposable). 1 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 The Dupont Merck Pharmaceutical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Dupont Merck Pharmaceutical Co. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Dupont Merck Pharmaceutical Co. 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 6 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.

  • K944866Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 19966cite it

What has FDA decided for it lately?

  • K944866Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 19961 recall

The one decision as The Dupont Merck Pharmaceutical Co. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K944866ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed…Mar 30, 2012

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

Dupont Medical Products 28Dupont Legal 2