# K140313: Stopsbleeding Topical Hemostat Powder and Foam

- Pathway: 510(k) (Traditional)
- Applicant: Coag Medical, LLC
- Decided: Jul 28, 2014 after 168 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.
1 later device descends from it; 1 cites it directly.
0 of 25 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.
- K013225: Instaclot for Otc Use, Traumasstat for Prescription Use, Medafor, Inc. (2001) Summary page 6.

## Most influential descendants
- K240097: Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (2024), 0 descendants of its own

## Indications for use
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use. Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are 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 are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional. OTC: StopsBleeding™ OTC Topical Hemostat Powder 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/K140313
Methodology: https://510kreport.com/methodology