# K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Jan 14, 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: 9 generations back to K953781 (1995). 74 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080097: Medtrade Products Celox Hemostatic Granules on Sheet, Medtrade Products, Ltd. (2008) Summary page 5.
- K090620: Quikclot Inteventional, Model P/N 182, Z-Medica Corporation (2009) Summary page 5.
- K061219: D-Stat Dry Hemostatic Bandage, Vascular Solutions, Inc. (2006) Summary page 5.
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing, Hem Con Medical Technologies, Inc. (2008) Summary page 5.

## Most influential descendants
- K190012: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid (2019), 0 descendants of its own
- K172155: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (2018), 0 descendants of its own

## Indications for use
CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters. or tubes utilizing introducer sheaths up to 18French"

Source page: https://510kreport.com/device/K093519
Methodology: https://510kreport.com/methodology