# K161013: InnoSEAL Hemostatic Pad

- Pathway: 510(k) (Traditional)
- Applicant: Innotherapy, Inc.
- Decided: Nov 29, 2016 after 232 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: 6 generations back to K914575 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K102944: Coreleader Hemo-Pad Model Cpii 02030, Coreleader Biotech Co., Ltd. (2011) Summary page 5.

## Indications for use
InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional. The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.

Source page: https://510kreport.com/device/K161013
Methodology: https://510kreport.com/methodology