510(k) Report

FDA applicant

Dupont Medical Products

Wilmington, DE28 decisions1991–19953 recalls

FDA records 28 decisions for Dupont Medical Products (Wilmington, DE) from 1991 to 1995: 28 510(k) clearances. Most are in product codes IXA (Cassette, Radiographic Film) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). 3 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Dupont Medical Products since 2007.

Recalls per year

2in 2018

2010: 12018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Dupont”

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