# K130324: Statseal Disc

- Pathway: 510(k) (Traditional)
- Applicant: Biolife, LLC
- Decided: Jul 9, 2013 after 151 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: 3 generations back to K002550 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080210: Pro QR Advanced Formula Powder, Biolife, LLC (2009) Summary page 6.
- K021678: Hemaderm Cotaining Hemadex Clotting Beads, Medafor, Inc. (2002) Summary page 6.

## Most influential descendants
- K254073: StatSeal Disc (2026), 0 descendants of its own

## Indications for use
Stat'Seal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns. StalSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Source page: https://510kreport.com/device/K130324
Methodology: https://510kreport.com/methodology