# K142363: Nustat, Nustat XR

- Pathway: 510(k) (Traditional)
- Applicant: Beeken Biomedical
- Decided: Jan 9, 2015 after 137 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: 9 generations back to K953781 (1995). 45 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072890: Stasilon FR, Entegrion, Inc. (2007) Summary page 6.
- K102546: Chitogauze, Hem Con Medical Technologies, Inc. (2010) Summary page 6.

## Most influential descendants
- 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
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions. NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

Source page: https://510kreport.com/device/K142363
Methodology: https://510kreport.com/methodology