510(k) Report

FDA applicant

Lange Medical Products, Inc.

Wheeling, IL4 decisions1994–19961 recall

FDA records 4 decisions for Lange Medical Products, Inc. (Wheeling, IL) from 1994 to 1996: 4 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). 1 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 Lange Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lange Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lange Medical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KMFBandage, Liquid2decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions

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.

  • K945000Multidex Hydrophilic Wound DressingLange Medical Products, Inc. · 19941cites it

What has FDA decided for it lately?

  • K962917Multidex Hydrophilic Wound Dressing GelLange Medical Products, Inc. · 1996
  • K955399Multidex Plus Hydrophilic Wound DressingLange Medical Products, Inc. · 1996
  • K952774Multidex GelLange Medical Products, Inc. · 1995
  • K945000Multidex Hydrophilic Wound DressingLange Medical Products, Inc. · 19941 recall

All 4 as Lange Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K945000Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703…Jan 19, 2004