510(k) Report

FDA applicant

Chitogen, Inc.

Minneapolis, MN2 decisions2009–20120 recalls

FDA records 2 decisions for Chitogen, Inc. (Minneapolis, MN) from 2009 to 2012: 2 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 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

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

FDA decisions per year

1in 2012

2009: 12012: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Chitogen, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K090100Softseal-STFChitogen, Inc. · 20092cite it

What has FDA decided for it lately?

  • K112864Softseal-CChitogen, Inc. · 2012
  • K090100Softseal-STFChitogen, Inc. · 2009

All 2 as Chitogen, Inc. →