# K093593: Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products Limited
- Decided: Jan 20, 2010 after 62 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: 3 generations back to K002550 (2000). 9 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules, Medtrade Products, Ltd. (2006) Summary page 7.
- K080210: Pro QR Advanced Formula Powder, Biolife, LLC (2009) Summary page 6.
- K021678: Hemaderm Cotaining Hemadex Clotting Beads, Medafor, Inc. (2002) Summary page 6.

## Most influential descendants
- 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
- K250319: Mfuse (MS001) (2025), 0 descendants of its own

## Indications for use
CELOX PRO for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. CELOX PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatmentfor controlling moderate to severe bleeding. CELOX PRO for minor external bleeding from wounds and procedures (OTC) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external, bleeding and exudate from sutures and/or surgical procedures.

Source page: https://510kreport.com/device/K093593
Methodology: https://510kreport.com/methodology