# K091133: Aplion Topical Care System

- Pathway: 510(k) (Traditional)
- Applicant: Aplion Medical,Llc
- Decided: May 20, 2009 after 30 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K811291 (1981). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020781: Wet Chamber, Kinetic Concepts, Inc. (2002) Summary page 1.
- K060046: Dermastream, Enzysurge, Ltd. (2006) Summary page 1.

## Indications for use
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.

Source page: https://510kreport.com/device/K091133
Methodology: https://510kreport.com/methodology