# K190129: AC5 Topical Gel

- Pathway: 510(k) (Traditional)
- Applicant: Arch Therapeutics, Inc.
- Decided: Mar 11, 2020 after 408 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: 4 generations back to K894541 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182681: AC5 Topical Gel, Arch Therapeutics, Inc. (2018) Summary page 5.

## 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/K190129
Methodology: https://510kreport.com/methodology