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Automatic Continuous Effusion Shunt (ACES) System

by Pleural Dynamics, Inc.

510(k) K231096

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231096 Date18 Aug 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Automatic Continuous Effusion Shunt (ACES) System ACES System
510(k) Number
FDA Product Code
KPM
Device Class
Class II
Regulation
21 CFR Part 876.5955
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Automatic Continuous Effusion Shunt (ACES) System is a Class II medical device designed for the management of recurrent pleural effusion. It is a fully implantable shunt system that automatically manages fluid drainage using the energy from normal breathing movements.

The ACES System is supplied as a single-use device and is implanted to provide continuous symptom relief without requiring an external catheter or drainage canisters. It is regulated under FDA 510(k) clearance with product code KPM and is intended for use in patients with symptomatic recurrent pleural effusion.

Other devices from Pleural Dynamics, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ACES System used for?

    The ACES System is designed for the management of recurrent pleural effusion. It is a fully implantable shunt system that automatically manages fluid drainage using the energy from normal breathing movements, providing continuous symptom relief without requiring an external catheter or drainage canisters.

  • Is the ACES System a single-use device?

    Yes, the ACES System is supplied as a single-use device. It is implanted to provide continuous symptom relief and is not intended to be reused after implantation.

  • What is the regulatory status of the ACES System?

    The ACES System is regulated under FDA 510(k) clearance with product code KPM. It has been determined to be substantially equivalent to predicate devices for the management of symptomatic recurrent pleural effusion.

  • How is the ACES System implanted and maintained?

    The ACES System is implanted as a fully implantable device that automatically manages fluid drainage using normal breathing movements. It does not require external catheters or drainage canisters for maintenance, providing continuous symptom relief to patients with recurrent pleural effusion.