# K183190: NuStat

- Pathway: 510(k) (Traditional)
- Applicant: Beeken Biomedical, LLC
- Decided: Sep 25, 2019 after 310 days
- Product code: POD (Temporary, Internal Use Hemostatic)
- Device class: 2
- Regulation: 21 CFR 878.4454
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160012 (2017). 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)
- DEN160012: D2 Dressing, Z-Medica, LLC (2017) Summary page 4.

## Recalls of this device
- Oct 14, 2021 · Class II · Z-0309-2022: Endotoxin levels exceeded allowable limits.

## Indications for use
NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Source page: https://510kreport.com/device/K183190
Methodology: https://510kreport.com/methodology