# K182681: AC5 Topical Gel

- Pathway: 510(k) (Traditional)
- Applicant: Arch Therapeutics, Inc.
- Decided: Dec 14, 2018 after 79 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: 3 generations back to K894541 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143058: PuraDerm Gel, 3-D Matrix, Inc. (2015) Summary page 5.
- K973806: Duoderm Hydroactive Gel, Convatec, A Bristol-Myers Squibb Co. (1997) Summary page 5.

## Most influential descendants
- K190129: AC5 Topical Gel (2020), 0 descendants of its own

## Indications for use
Under the supervision of a health care professional, AC5 Topical Gel is a topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

Source page: https://510kreport.com/device/K182681
Methodology: https://510kreport.com/methodology