# K091194: Algiseal Pad

- Pathway: 510(k) (Traditional)
- Applicant: Evolution Medical Technologies, LLC
- Decided: May 18, 2009 after 25 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 K984177 (1998). 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)
- K941176: Alginate Fiber, Adri/Technam (1994) Summary page 5.
- K914779: Alginate Fiber, Adri/Technam (1991) Summary page 5.
- K040208: Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band, Tz Medical, Inc. (2004) Summary page 5.

## Most influential descendants
- K101097: Calgaeseal Model: Cas (2010), 0 descendants of its own

## Indications for use
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following sirgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.

Source page: https://510kreport.com/device/K091194
Methodology: https://510kreport.com/methodology