# Acell, Inc.

- Location (FDA's records): Columbia, MD
- FDA decisions: 20 (2002–2024): 20 510(k) clearances
- Product codes: KGN (13), FTM (6), PSQ (1)
- 510(k) review time since 2016: median 54 days, against 132 for FDA's reviews in the same codes and years (9 of 10 faster)
- Predicates its devices cite: 28 (18 its own); citations of its devices by later devices: 27 (18 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Biotech, Inc.: 6 (https://510kreport.com/company/cook-biotech)
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)
- Acrymed, Inc.: 1 (https://510kreport.com/company/acrymed)
- Collagen Matrix, Inc.: 1 (https://510kreport.com/company/collagen-matrix)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Nextgen Biologics, Inc.: 2 (https://510kreport.com/company/nextgen-biologics)
- Stemsys: 1 (https://510kreport.com/company/stemsys)
- Aeon Astron Europe B.V.: 1 (https://510kreport.com/company/aeon-astron-europe)
- Geistlich Pharma AG: 1 (https://510kreport.com/company/geistlich-pharma)
- Collamatrix Co., Inc.: 1 (https://510kreport.com/company/collamatrix)
- Kerecis Limited: 1 (https://510kreport.com/company/kerecis)
- Mesynthes, Ltd.: 1 (https://510kreport.com/company/mesynthes)
- Ecm Therapeutics, Inc.: 1 (https://510kreport.com/company/ecm-therapeutics)

## Its most-cited devices
- K152721: Cytal Wound Matrix (2015), cited by 5
- K021637: Acell Ubm Lyophilized Wound Dressing (2002), cited by 5
- K060888: Acell Powder Wound Dressing (2006), cited by 3
- K112409: Matristem Wound Matrix (2011), cited by 2
- K172399: MicroMatrix (2017), cited by 2
- K092926: Acell Matristem Wound Sheet (2009), cited by 2

## Recent decisions
- K241706: MicroMatrix® UBM Particulate (Jul 11, 2024)
- K241724: Cytal® Wound Matrix; Cytal® Burn Matrix (Jul 11, 2024)
- K230980: MicroMatrix® Flex (Sep 22, 2023)
- K191734: MatriStem UBM Pericardial Patch (Nov 22, 2019)
- K192725: Cytal Wound Matrix 3-Layer (Oct 25, 2019)
- K182259: Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (Feb 7, 2019)
- K180776: Cytal Wound Particulate (May 11, 2018)
- K172399: MicroMatrix (Oct 6, 2017)

Source page: https://510kreport.com/company/acell