510(k) Report

FDA applicant

Medafor, Inc.

Minneapolis, MN4 decisions2001–20130 recalls

FDA records 4 decisions for Medafor, Inc. (Minneapolis, MN) from 2001 to 2013: 4 510(k) clearances. Most are in product codes QSY (Hemostatic Wound Dressing Without Thrombin Or…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 12 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medafor, 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?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • KMFBandage, Liquid1decision

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 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.

  • K021678Hemaderm Cotaining Hemadex Clotting BeadsMedafor, Inc. · 20025cite it
  • K013225Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 20015cite it
  • K033666HemadermMedafor, Inc. · 20034cite it
  • K123325Medafor Direct Gas-Assisted Application SystemMedafor, Inc. · 20131cites it

What has FDA decided for it lately?

  • K123325Medafor Direct Gas-Assisted Application SystemMedafor, Inc. · 2013
  • K033666HemadermMedafor, Inc. · 2003
  • K021678Hemaderm Cotaining Hemadex Clotting BeadsMedafor, Inc. · 2002
  • K013225Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 2001

All 4 as Medafor, Inc. →