# K122297: Enluxtra Humifiber Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Basf Venture Capital America, Inc.
- Decided: Aug 28, 2012 after 28 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: 2 generations back to K933495 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092351: Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings, Polyremedy, Inc. (2010) Summary page 1.
- K981150: Solosite Gel Conformable Dressing, Smith & Nephew, Inc. (1998) Summary page 1.
- (no number) Enluxtra Humifiber Wound Dressing: named in the summary without a submission number

## Indications for use
Enluxtra HumiflberT " Wound Dressings are intended as an effective barrier to reduce microbial penetration through the dressing. The Enluxtra Humifiber' M Wound Dressings are for use under healthcare professional's orders for the management of exuding wounds, partial and full thickness wounds, such as pressure ulcers (Stages Il-IY), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds.

Source page: https://510kreport.com/device/K122297
Methodology: https://510kreport.com/methodology