# K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Dec 3, 2010 after 98 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: 5 generations back to K821150 (1982). 23 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam, Hemostasis, LLC (2007) Summary page 6.
- K033666: Hemaderm, Medafor, Inc. (2003) Summary page 6.

## Most influential descendants
- K120958: Posisep and Posisep X Hemostat Dressings (2012), 6 descendants of its own
- K141704: Novashield Injectable Nasal Packing and Stent (2014), 2 descendants of its own
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), 2 descendants of its own
- K172179: Chitogel Endoscopic Sinus Surgery Kit (2017), 1 descendant of its own
- K230142: Epi-Stop Nasal Gel/epistaxis pack (2023), 0 descendants of its own

## Indications for use
NexStat® Topical Hemostat Powder and NexFoam® 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/K102459
Methodology: https://510kreport.com/methodology