510(k) Report

FDA applicant

Kenpak Converters, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Kenpak Converters, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code FRG (Wrap, Sterilization). 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, general hospital panel, where it files most

How often FDA has decided Kenpak Converters, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kenpak Converters, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kenpak Converters, Inc. 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?

  • FRGWrap, Sterilization1decision

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.

  • K831425MDT Chemitest See-Thru BagKenpak Converters, Inc. · 19831cites it

What has FDA decided for it lately?

  • K831425MDT Chemitest See-Thru BagKenpak Converters, Inc. · 1983

The one decision as Kenpak Converters, Inc. →