# K254168: Actolind® (06.3637.  Actolind® Gel Plus)

- Pathway: 510(k) (Traditional)
- Applicant: ACTO GmbH
- Decided: Sep 22, 2026 after 273 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: 8 generations back to K914579 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163430: Prontosan Wound Gel, B.Braun Medical, Inc. (2017) Summary page 5.

## Indications for use
OTC Use: Actolind® Gel Plus is intended to cleanse and moisten the wound bed and for the management of minor cuts, minor abrasions, minor lacerations, and minor burns. Professional Use: Actolind® Gel Plus is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and superficial partial thickness (2nd degree) burns, partial and full thickness wounds, large surface area wounds and surgical incisions.

Source page: https://510kreport.com/device/K254168
Methodology: https://510kreport.com/methodology