# K072890: Stasilon FR

- Pathway: 510(k) (Traditional)
- Applicant: Entegrion, Inc.
- Decided: Dec 10, 2007 after 61 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 8 generations back to K953781 (1995). 34 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043050: Hemcon Bandage and Hemcon Bandage Otc, Hemcon, Inc. (2005) Summary page 6.
- K051955: Quickclot Acs - Accelerated Clotting Sponge, Z-Medica Corporation (2005) Summary page 6.
- K061219: D-Stat Dry Hemostatic Bandage, Vascular Solutions, Inc. (2006) Summary page 6.
- K053300: Syvekexcel, Marine Polymer Technologies, Inc. (2006) Summary page 6.

## Most influential descendants
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own
- K232847: SiOxD Wound Matrix (2023), 1 descendant of its own
- K241660: SiOxD® Wound Matrix (2024), 0 descendants of its own
- K160578: Nustat XR (2016), 0 descendants of its own

## Indications for use
Stasilon FR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions. Stasilon FR™ is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.

Source page: https://510kreport.com/device/K072890
Methodology: https://510kreport.com/methodology