# K190012: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Product, Ltd.
- Decided: Dec 18, 2019 after 349 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: 10 generations back to K953781 (1995). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet, Medtrade Products, Ltd. (2010) Summary page 6.

## Indications for use
OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French

Source page: https://510kreport.com/device/K190012
Methodology: https://510kreport.com/methodology