510(k) Report

FDA applicant

Kytogenics, Inc.

Chatham, NJ1 decision2008–20080 recalls

FDA records 1 decision for Kytogenics, Inc. (Chatham, NJ) in 2008: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). 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

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

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Kytogenics, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)1decision

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.

  • K080010Nocc Hydrophilic Wound DressingKytogenics, Inc. · 20082cite it

What has FDA decided for it lately?

  • K080010Nocc Hydrophilic Wound DressingKytogenics, Inc. · 2008

The one decision as Kytogenics, Inc. →