# K080210: Pro QR Advanced Formula Powder

- Pathway: 510(k) (Traditional)
- Applicant: Biolife, LLC
- Decided: Feb 10, 2009 after 379 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: 2 generations back to K002550 (2000). 5 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070520: Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures), Biolife, LLC (2007) Summary page 5.
- K021678: Hemaderm Cotaining Hemadex Clotting Beads, Medafor, Inc. (2002) Summary page 5.
- K013390: Quickclot, On Site Gas Systems, Inc. (2002) Summary page 5.

## Most influential descendants
- K093593: Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro (2010), 13 descendants of its own
- K113560: Celox Gauze Pro (2012), 11 descendants of its own
- K133121: Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam Active, 3INX6FT (2014), 5 descendants of its own
- K240713: Traumagel® (2024), 2 descendants of its own
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (2015), 2 descendants of its own

## Indications for use
PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.

Source page: https://510kreport.com/device/K080210
Methodology: https://510kreport.com/methodology