# K983554: Alldress, Absorbent Film Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Nov 10, 1998 after 28 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- 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. The FDA summary names its predicate without a number.
- (no number) Alldress® Multi-Layered Wound Dressing: named in the summary without a submission number

## Indications for use
Alidress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic uicers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

Source page: https://510kreport.com/device/K983554
Methodology: https://510kreport.com/methodology