# K090620: Quikclot Inteventional, Model P/N 182

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica Corporation
- Decided: Apr 8, 2009 after 30 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: 8 generations back to K953781 (1995). 71 ancestors in all.
5 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)
- K072474: Quikclot EX, Z-Medica Corporation (2007) 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)

## Most influential descendants
- K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet (2010), 2 descendants of its own
- K120782: Interventional Hemostatic Bandage (2013), 1 descendant of its own
- K190012: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid (2019), 0 descendants of its own
- K181641: QuikClot Radial (2018), 0 descendants of its own
- K172155: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (2018), 0 descendants of its own

## Indications for use
QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

Source page: https://510kreport.com/device/K090620
Methodology: https://510kreport.com/methodology