# K023138: Hydrofera Bacteriostatic Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hydrofera, LLC
- Decided: Jan 17, 2003 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin. Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have. Hydrofera Bacteriostatic Wound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial bums, post surgical incisions, and other external wounds inflicted by trauma.

Source page: https://510kreport.com/device/K023138
Methodology: https://510kreport.com/methodology