510(k) Report

FDA applicant

Pro-Pak

Mchenry, IL3 decisions1982–19820 recalls

FDA records 3 decisions for Pro-Pak (Mchenry, IL) in 1982: 3 510(k) clearances. All are in product code KDD (Kit, Surgical Instrument, Disposable). 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 and plastic surgery panel, where it files most

How often FDA has decided Pro-Pak’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro-Pak since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pro-Pak 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?

  • KDDKit, Surgical Instrument, Disposable3decisions

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.

  • K821501Sterile Tracheostomy Care KitPro-Pak · 19821cites it

What has FDA decided for it lately?

  • K821502Sterile Suture Removal KitPro-Pak · 1982
  • K821500Sterile Cath Care KitPro-Pak · 1982
  • K821501Sterile Tracheostomy Care KitPro-Pak · 1982

All 3 as Pro-Pak →