510(k) Report

FDA applicant

Medipack Medical Packaging Mfg. Co.

Mc Henry, IL2 decisions1999–20040 recalls

FDA records 2 decisions for Medipack Medical Packaging Mfg. Co. (Mc Henry, IL) from 1999 to 2004: 2 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and KCT (Sterilization Wrap Containers, Trays…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Medipack Medical Packaging Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medipack Medical Packaging Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medipack Medical Packaging Mfg. Co. 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?

  • FXXMask, Surgical1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 19992cite it

What has FDA decided for it lately?

  • K034015Earloop Procedure MaskMedipack Medical Packaging Mfg. Co. · 2004
  • K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999

All 2 as Medipack Medical Packaging Mfg. Co. →