# K972914: Syvek Patch

- Pathway: 510(k) (Traditional)
- Applicant: Marine Polymer Technologies, Inc.
- Decided: Dec 22, 1997 after 137 days
- Product code: KGX (Tape And Bandage, Adhesive)
- Device class: 1
- Regulation: 21 CFR 880.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
99 later devices descend from it; 2 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023298: Hemcon Bandage (2002), 74 descendants of its own
- K030946: Hemcon Bandage Otc; Hemcon Cath/Aid (2003), 56 descendants of its own
- K043050: Hemcon Bandage and Hemcon Bandage Otc (2005), 55 descendants of its own
- K030334: T-Scientific T-Pad (2003), 44 descendants of its own
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc (2008), 35 descendants of its own

## Indications for use
The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K972914
Methodology: https://510kreport.com/methodology