# K061722: Bloxx Rapid Clotting Agent

- Pathway: 510(k) (Traditional)
- Applicant: Crosslink-D, Inc.
- Decided: Aug 2, 2006 after 44 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: 1 generation back to K013225 (2001). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K082703: MRDH Bandage (2008), 3 descendants of its own
- K103641: Guardacare (2011), 2 descendants of its own
- K140757: D2 Hemostantic Dressing (2014), 1 descendant of its own
- K243553: QuikClot Control+ Hemostatic Device (2025), 0 descendants of its own

## Indications for use
BloxxTM Rapid Clotting Agent is a hemostatic gauze pad intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, post operative, donor sites, dermatological, etc.), and traumatic injuries.

Source page: https://510kreport.com/device/K061722
Methodology: https://510kreport.com/methodology