# K213092: Cellusheet, Cellufil

- Pathway: 510(k) (Special)
- Applicant: Human Biosciences, Inc.
- Decided: Dec 15, 2021 after 82 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913023 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122325: Skintemp II, Human Biosciences, Inc. (2012) Summary page 4.
- K910944: Medifil, Biocore (1991) Summary page 4.
- K925545: Skintemp, Modification, Biocore (1993) Summary page 4.

## Most influential descendants
- K232758: Comatryx OTC (2023), 0 descendants of its own

## Indications for use
The device is intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor bums.

Source page: https://510kreport.com/device/K213092
Methodology: https://510kreport.com/methodology