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The Tracker / September 2026 / K254168

510(k) cleared

Actolind® (06.3637. Actolind® Gel Plus)

ACTO GmbH · Sep 22, 2026 · K254168

FDA cleared the Actolind® (06.3637. Actolind® Gel Plus) from ACTO GmbH on Sep 22, 2026 under K254168, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 23, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for ACTO GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254168?

K254168 is the FDA 510(k) for Actolind® (06.3637. Actolind® Gel Plus), submitted by ACTO GmbH. FDA's decision date was Sep 22, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Actolind® (06.3637. Actolind® Gel Plus)?

ACTO GmbH, based in Braunschweig, is the applicant of record for K254168.

How long did the K254168 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 22, 2026, 273 days later.

← All decisions in September 2026