# K250115: Hemastyl (™) Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Nexus Nanotech Wound Solutions, Inc.
- Decided: Oct 14, 2025 after 271 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 1 generation back to K083103 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B, Acrymed, Inc. (2009) Summary page 5.

## Indications for use
The Hemastyl Wound Gel is indicated for use as follows: Hemastyl Wound Gel Rx: Management of wounds such • 1st degree burns and 2nd degree superficial burns • stasis ulcers • pressure ulcers • diabetic ulcers • lacerations • abrasions • skin tears • surgical incision sites • device insertion site wounds • graft sites • donor sites OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.

Source page: https://510kreport.com/device/K250115
Methodology: https://510kreport.com/methodology