510(k) Report

FDA applicant

Nextgen Biologics, Inc.

Alachua, FL2 decisions2018–20210 recalls

FDA records 2 decisions for Nextgen Biologics, Inc. (Alachua, FL) from 2018 to 2021: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 4 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 Nextgen Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Nextgen Biologics, Inc. by year, 2018–2026Sources: 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)2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K181330NeoMatriX Wound MatrixNextgen Biologics, Inc. · 20181cites it

What has FDA decided for it lately?

  • K210024NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2021
  • K181330NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2018

All 2 as Nextgen Biologics, Inc. →