# K160578: Nustat XR

- Pathway: 510(k) (Traditional)
- Applicant: Beeken Biomedical, LLC
- Decided: Jun 29, 2016 after 120 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: 10 generations back to K953781 (1995). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142363: Nustat, Nustat XR, Beeken Biomedical (2015) Summary page 5.

## Indications for use
OTC: NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions. Rx: NuStat is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions, surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Source page: https://510kreport.com/device/K160578
Methodology: https://510kreport.com/methodology