# K033291: Topseal Hemostatic Dressing, Model 11150

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Mar 17, 2004 after 155 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: 4 generations back to K953781 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024107: Femostop Femoral Compression System, Radi Medical Systems AB (2002) Summary page 5.
- K021678: Hemaderm Cotaining Hemadex Clotting Beads, Medafor, Inc. (2002) Summary page 5.
- K021581: Hemosorb, On Site Gas Systems, Inc. (2002) Summary page 5.

## Indications for use
TopSeal T M Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.

Source page: https://510kreport.com/device/K033291
Methodology: https://510kreport.com/methodology