# K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Apr 5, 2007 after 73 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: 4 generations back to K821150 (1982). 22 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033666: Hemaderm, Medafor, Inc. (2003) Summary page 5.
- K013225: Instaclot for Otc Use, Traumasstat for Prescription Use, Medafor, Inc. (2001) Summary page 5.

## Most influential descendants
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge (2010), 9 descendants of its own
- K120958: Posisep and Posisep X Hemostat Dressings (2012), 6 descendants of its own
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own

## Indications for use
The Hemostasis, LLC Wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: TraumArrest MT is indicated for use 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 is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. OTC: BleedArrestTM particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

Source page: https://510kreport.com/device/K070211
Methodology: https://510kreport.com/methodology