# K254034: Roosin Collagen Powder

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Co., Ltd.
- Decided: Jun 3, 2026 after 169 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 K012990 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171645: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle, Strukmyer Medical (2017) Summary page 5.

## Indications for use
Roosin Collagen Powder is used in the management of partial and full thickness wounds, 1st and superficial 2nd degree burns, pressure (stage I-IV) ulcers, scrapes, abrasions, venous ulcers, diabetic ulcers, and surgical wounds.

Source page: https://510kreport.com/device/K254034
Methodology: https://510kreport.com/methodology