# K112864: Softseal-C

- Pathway: 510(k) (Traditional)
- Applicant: Chitogen, Inc.
- Decided: Aug 2, 2012 after 307 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)
- K090100: Softseal-STF, Chitogen, Inc. (2009)

## Cited in the summary but kept off the family tree
- K030904: Palamed, Heraeus Medical GmbH Technology (2003). Our reading of the summary gave K030904, FDA’s number for Palamed (Heraeus Medical GmbH Technology). Its FDA name has none of the distinctive words the summary uses for the device it names, “HemCon Bandage-OTC”. Kept off the family tree.

## Indications for use
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.

Source page: https://510kreport.com/device/K112864
Methodology: https://510kreport.com/methodology