510(k) Report

FDA applicant

Keranetics

Winston Salem, NC2 decisions2017–20200 recalls

FDA records 2 decisions for Keranetics (Winston Salem, NC) from 2017 to 2020: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Keranetics, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

1in 2020

2017: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Keranetics by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Keranetics’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?

  • KGNWound Dressing With Animal-Derived Material (S)2decisions

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162759KeraStat (R) GelKeranetics, LLC · 20171cites it

What has FDA decided for it lately?

  • K192386KeraStat CreamKeranetics · 2020
  • K162759KeraStat (R) GelKeranetics, LLC · 2017

The one decision as Keranetics →The one decision as Keranetics, LLC →