# K984599: Modification of Cutinova Foam 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 K922681 (1992). 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)
- K922681: Cutinova Foam, Jobst Institute, Inc. (1992) Summary page 1.

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

Source page: https://510kreport.com/device/K984599
Methodology: https://510kreport.com/methodology