510(k) Report

FDA applicant

Acell, Inc.

Columbia, MD20 decisions2002–20247 recalls

FDA records 20 decisions for Acell, Inc. (Columbia, MD) from 2002 to 2024: 20 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and FTM (Mesh, Surgical). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 18 of them its own earlier devices. 7 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2024

2009: 12011: 12015: 22016: 22017: 22018: 12019: 32023: 12024: 2
2007high 3 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

5in 2026

2019: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Acell, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acell, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)13decisions
  • FTMMesh, Surgical6decisions
  • PSQIntracardiac Patch Or Pledget, Biologically Derived1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 54 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 9 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 28 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 18 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.

  • K152721Cytal Wound MatrixAcell, Inc. · 20155cite it
  • K021637Acell Ubm Lyophilized Wound DressingAcell, Inc. · 20025cite it
  • K060888Acell Powder Wound DressingAcell, Inc. · 20063cite it
  • K112409Matristem Wound MatrixAcell, Inc. · 20112cite it
  • K172399MicroMatrixAcell, Inc. · 20172cite it
  • K092926Acell Matristem Wound SheetAcell, Inc. · 20092cite it

What has FDA decided for it lately?

  • K241706MicroMatrix® UBM ParticulateAcell, Inc. · 2024
  • K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc. · 2024
  • K230980MicroMatrix® FlexAcell, Inc. · 2023
  • K191734MatriStem UBM Pericardial PatchAcell, Inc. · 2019
  • K192725Cytal Wound Matrix 3-LayerAcell, Inc. · 2019
  • K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. · 2019
  • K180776Cytal Wound ParticulateAcell, Inc. · 2018
  • K172399MicroMatrixAcell, Inc. · 2017

All 20 as Acell, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K152721Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Mar 19, 2026Class II
  • K152721Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.Mar 19, 2026Class II
  • K152721Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Mar 19, 2026Class II
  • K152721Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.Mar 19, 2026Class II
  • K152721Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Mar 19, 2026Class II
  • K170763Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product…Feb 14, 2019Class II