# K231096: Automatic Continuous Effusion Shunt (ACES) System ACES System

- Pathway: 510(k) (Traditional)
- Applicant: Pleural Dynamics, Inc.
- Decided: Aug 18, 2023 after 122 days
- Product code: KPM (Shunt, Peritoneal)
- Device class: 2
- Regulation: 21 CFR 876.5955
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822686 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822686: Denver Peritoneo-Venous Shunt (DP-VS), Denver Biomedicals, Inc. (1982) Summary page 6.

## Indications for use
The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion

Source page: https://510kreport.com/device/K231096
Methodology: https://510kreport.com/methodology