# K013462: Hydrofera Bacteriostatic Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hydrofera, LLC
- Decided: Jan 11, 2002 after 85 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: 1 generation back to K983276 (1999). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983276: Hydrofera Bacteristatic Nasal Dressing, Hydrofera, LLC (1999). Our OCR of the scanned summary read K983270, FDA’s number for Voyager Quad Cannula (Cardiothoracic Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Hydrofera Bacteriostatic Nasal Dressing”.
- (no number) Uttrafera wound dressing: named in the summary without a submission number

## Most influential descendants
- K060832: Retro-Tech Dressing (2007), 2 descendants of its own
- K130670: Hydrofera Blue PU Bacteriostatic Dressing (2014), 1 descendant of its own
- K190268: Hydrofera Blue READY - Border (2019), 0 descendants of its own

## Indications for use
Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, domor sites,-venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial bt post-surgical incisions, and other external wounds .inflicted by trauma.

Source page: https://510kreport.com/device/K013462
Methodology: https://510kreport.com/methodology