# K112961: Clo-Surplus P.a.D.

- Pathway: 510(k) (Special)
- Applicant: Scion Cardio-Vascular, Inc.
- Decided: Oct 31, 2011 after 27 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: 1 generation back to K092552 (2009). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092552: Clo-Surplus P.a.D., Scion Cardio-Vascular, Inc. (2009) Summary page 5.

## Most influential descendants
- K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO (2015), 3 descendants of its own
- K182811: gel-e Flex+ (2019), 1 descendant of its own
- K202830: Axiostat Patch (2021), 0 descendants of its own
- K192667: gel-e Flex+ gel OTC (2019), 0 descendants of its own

## Indications for use
The Scion Cardio-Vascular Clo-Sur™S P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites, and sites involving percutaneous catheters, tubes and pins.

Source page: https://510kreport.com/device/K112961
Methodology: https://510kreport.com/methodology