FDA applicant

Kit Pak, Inc.

Elk Grove Village, IL13 decisions1989–19950 recalls

FDA records 13 decisions for Kit Pak, Inc. (Elk Grove Village, IL) from 1989 to 1995: 13 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and KNY (Accessories, Catheter, G-U). 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 Kit Pak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kit Pak, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kit Pak, Inc.

Which product codes does it file in?

What has FDA decided for it lately?