Cleared Traditional

Automatic Continuous Effusion Shunt (ACES) System ACES System (K231096) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231096 · Pleural Dynamics, Inc. · Gastroenterology & Urology device
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Aug 2023
Decision
122d
Days
Class 2
Risk

K231096 is an FDA 510(k) clearance for the Automatic Continuous Effusion Shunt (ACES) System ACES System. Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Pleural Dynamics, Inc. (Wayzata, US). The FDA issued a Cleared decision on August 18, 2023 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5955 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pleural Dynamics, Inc. devices

Submission Details

510(k) Number K231096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2023
Decision Date August 18, 2023
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 130d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPM Shunt, Peritoneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5955
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Ostendorf Consulting, LLC
Joseph Ostendorf

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPM Shunt, Peritoneal

Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K231096.
LEVEEN PERITINEO-VENOUS SHUNT
K901360 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
DENVER PERITONEO-VENUS SHUNT
K894756 · Codman & Shurtleff, Inc. · Sep 1989
DENVER PLEURO-PERITONEAL SHUNT
K880570 · Codman & Shurtleff, Inc. · Jun 1988
DENVER PERITONEO-VENOUS SHUNT
K880401 · Codman & Shurtleff, Inc. · May 1988
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · Cordis Corp. · Jan 1981
VALVE, ASCITES, LAVEEN
K770602 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1977