# K101097: Calgaeseal Model: Cas

- Pathway: 510(k) (Traditional)
- Applicant: Bz Medical, Inc.
- Decided: Sep 22, 2010 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 K984177 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K091194: Algiseal Pad, Evolution Medical Technologies, LLC (2009) Summary page 5.

## Indications for use
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis 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/K101097
Methodology: https://510kreport.com/methodology