# K152721: Cytal Wound Matrix

- Pathway: 510(k) (Special)
- Applicant: Acell, Inc.
- Decided: Dec 8, 2015 after 78 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921895 (1992). 26 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112409: Matristem Wound Matrix, Acell, Inc. (2011) Summary page 4.

## Most influential descendants
- K192725: Cytal Wound Matrix 3-Layer (2019), 1 descendant of its own
- K181330: NeoMatriX Wound Matrix (2018), 1 descendant of its own
- K241724: Cytal® Wound Matrix; Cytal® Burn Matrix (2024), 0 descendants of its own
- K213607: Geistlich Wound Matrix PLUS (2022), 0 descendants of its own
- K210024: NeoMatriX Wound Matrix (2021), 0 descendants of its own

## Recalls of this device
- Mar 19, 2026 · Class II · Z-1816-2026: Increased rate of out-of-specification endotoxin results.
- Mar 19, 2026 · Class II · Z-1819-2026: Increased rate of out-of-specification endotoxin results.
- Mar 19, 2026 · Class II · Z-1817-2026: Increased rate of out-of-specification endotoxin results.
- Mar 19, 2026 · Class II · Z-1820-2026: Increased rate of out-of-specification endotoxin results.
- Mar 19, 2026 · Class II · Z-1818-2026: Increased rate of out-of-specification endotoxin results.

## Indications for use
Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K152721
Methodology: https://510kreport.com/methodology