# K021062: Chito-Seal

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Aug 23, 2002 after 143 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: 1 generation back to K984177 (1998). 1 ancestor in all.
48 later devices descend from it; 5 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984177: Modification to Skvekpatch, Marine Polymer Technologies, Inc. (1998) Summary page 5.

## Most influential descendants
- K032986: Clo-Surplusp.a.D. (2004), 25 descendants of its own
- K053300: Syvekexcel (2006), 14 descendants of its own
- K040208: Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band (2004), 14 descendants of its own
- K061219: D-Stat Dry Hemostatic Bandage (2006), 13 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own

## Indications for use
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K021062
Methodology: https://510kreport.com/methodology