510(k) Report

FDA applicant

Corpak Co.

Wheeling, IL24 decisions1981–199815 recalls

FDA records 24 decisions for Corpak Co. (Wheeling, IL) from 1981 to 1998: 24 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and CAF (Nebulizer (Direct Patient Interface)). 15 recalls are linked to its devices.

FDA’s records also spell it “Corpak, Inc.”.

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 Corpak Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Corpak Co. since 2007.

Recalls per year

8in 2026

2011: 12017: 32019: 22020: 12026 (partial year): 8
2007high 8 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Corpak”

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