# K965034: Sorbastace

- Pathway: 510(k) (Traditional)
- Applicant: Hemostace, LLC
- Decided: Apr 9, 1998 after 478 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
No predicates in its family tree.
52 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Iodosorb Powder: named in the summary without a submission number
- (no number) Intrasite Cavity Wound Dressing: named in the summary without a submission number
- (no number) Kaltostat Wound Dressing: named in the summary without a submission number
- (no number) ClearSite Hydrogel Wound Dressing: named in the summary without a submission number
- (no number) DeRoyal Hydrogel Dressing: named in the summary without a submission number

## Most influential descendants
- K021581: Hemosorb (2002), 40 descendants of its own
- K070010: Quikclot Sport and Quikclot Sport Silver (2007), 38 descendants of its own
- K072474: Quikclot EX (2007), 36 descendants of its own
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266 (2009), 20 descendants of its own
- K070520: Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures) (2007), 17 descendants of its own

## Indications for use
Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.

Source page: https://510kreport.com/device/K965034
Methodology: https://510kreport.com/methodology