# K090100: Softseal-STF

- Pathway: 510(k) (Traditional)
- Applicant: Chitogen, Inc.
- Decided: Mar 11, 2009 after 55 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: 5 generations back to K914575 (1991). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032986: Clo-Surplusp.a.D., Scion Cardio-Vascular, Inc. (2004) Summary page 5.

## Most influential descendants
- K220566: Vascette HP (hemostatic pad) (2022), 0 descendants of its own
- K112864: Softseal-C (2012), 0 descendants of its own

## Indications for use
SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K090100
Methodology: https://510kreport.com/methodology