# K082703: MRDH Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Marine Polymer Technologies, Inc.
- Decided: Oct 14, 2008 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
Longest line of descent: 2 generations back to K013225 (2001). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002550: RDH Bandage, Marine Polymer Technologies, Inc. (2000) Summary page 1.
- K013225: Instaclot for Otc Use, Traumasstat for Prescription Use, Medafor, Inc. (2001) Summary page 1.
- K061722: Bloxx Rapid Clotting Agent, Crosslink-D, Inc. (2006) Summary page 1.

## Most influential descendants
- K103641: Guardacare (2011), 2 descendants of its own
- K140757: D2 Hemostantic Dressing (2014), 1 descendant of its own
- K243553: QuikClot Control+ Hemostatic Device (2025), 0 descendants of its own

## Indications for use
mRDH Bandage is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.

Source page: https://510kreport.com/device/K082703
Methodology: https://510kreport.com/methodology