510(k) Report

FDA applicant

Cell Constructs I, LLC

Woodstock, GA1 decision2019–20191 recall

FDA records 1 decision for Cell Constructs I, LLC (Woodstock, GA) in 2019: 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. 1 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 Cell Constructs I, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2019high 1 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Cell Constructs I, LLC by year, 2019–2026Sources: 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:

What has FDA decided for it lately?

  • K182010ProgenaMatrixCell Constructs I, LLC · 20191 recall

The one decision as Cell Constructs I, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K182010progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1)…Apr 18, 2022Class II

Other applicant names beginning “Cell”

FDA records each applicant name separately; these may or may not be the same firm.

Cell Robotics, Inc. 9Cell Analysis, Inc. 1Cell Gen Therapeutics, LLC 1Cell Bio-Systems, Inc. 1Cell Ent., Inc. 1Cell Culture Laboratories 1Cell Store (Beijing) Biotechnology CO., LTD. 1