# K984177: Modification to Skvekpatch

- Pathway: 510(k) (Traditional)
- Applicant: Marine Polymer Technologies, Inc.
- Decided: Dec 18, 1998 after 28 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
120 later devices descend from it; 10 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K021062: Chito-Seal (2002), 48 descendants of its own
- K012293: Vascular Solutions Duett Flowable Hemostat (2002), 45 descendants of its own
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage (2003), 44 descendants of its own

## Indications for use
ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds. SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

Source page: https://510kreport.com/device/K984177
Methodology: https://510kreport.com/methodology