# K130670: Hydrofera Blue PU Bacteriostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hydrofera, LLC
- Decided: Jan 2, 2014 after 296 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 5 generations back to K946245 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013462: Hydrofera Bacteriostatic Wound Dressing, Hydrofera, LLC (2002) Summary page 2.
- K060832: Retro-Tech Dressing, Retro-Tech, LLC (2007) Summary page 1.

## Most influential descendants
- K190268: Hydrofera Blue READY - Border (2019), 0 descendants of its own

## Indications for use
Hydrafera Blue PU Antibacterial Wound Dressings are intended as exteral dressings for use In local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.

Source page: https://510kreport.com/device/K130670
Methodology: https://510kreport.com/methodology