# K122886: Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing

- Pathway: 510(k) (Special)
- Applicant: Hemostasis, LLC
- Decided: Nov 15, 2012 after 56 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: 6 generations back to K821150 (1982). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge, Hemostasis, LLC (2010) Summary page 6.
- K033666: Hemaderm, Medafor, Inc. (2003) Summary page 6.

## Indications for use
Nextat® Plus Topical Hemostat Powder and Nexoam® Plus Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

Source page: https://510kreport.com/device/K122886
Methodology: https://510kreport.com/methodology