# K190268: Hydrofera Blue READY - Border

- Pathway: 510(k) (Traditional)
- Applicant: Hydrofera, LLC
- Decided: Nov 6, 2019 after 271 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: 6 generations back to K946245 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130670: Hydrofera Blue PU Bacteriostatic Dressing, Hydrofera, LLC (2014) Summary page 4.

## Indications for use
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.

Source page: https://510kreport.com/device/K190268
Methodology: https://510kreport.com/methodology