# K984595: Modification of Cutinova Hydro Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Beiersdorf-Jobt, Inc.
- Decided: Mar 1, 1999 after 63 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 K905688 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905688: Cutinova Hydro, Beiersdorf, Inc. (1991) Summary page 1.

## Indications for use
Cutinova hydro may be used under the direction of a health care professional for the management of surface, moderately to highly exudating wounds such as: Leg ulcers Pressure ulcers Second degree burns Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as: Leg ulcers Stage I-IV pressure ulcers First and second degree burns:

Source page: https://510kreport.com/device/K984595
Methodology: https://510kreport.com/methodology