# K050511: Thrombigel Thrombin/Gelatin Foam Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 14, 2005 after 44 days
- Product code: QSX (Hemostatic Wound Dressing With 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: 4 generations back to K896068 (1990). 5 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003). Our reading of the summary gave K130836, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Vascular Solutions, Inc., in this field.

## Cited in the summary but kept off the family tree
- K122093: D-Stat Flowable Hemostat. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Most influential descendants
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K120958: Posisep and Posisep X Hemostat Dressings (2012), 6 descendants of its own
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO (2015), 3 descendants of its own

## Indications for use
The ThrombiGel thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Source page: https://510kreport.com/device/K050511
Methodology: https://510kreport.com/methodology