510(k) Report

510(k) · Cleared

Cleared

Automatic Continuous Effusion Shunt (ACES) System ACES System

K231096510(k) TraditionalCleared Aug 18, 2023122-day reviewClass II21 CFR 876.5955

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pleural Dynamics, Inc. · KPM Shunt, Peritoneal

Cleared on Aug 18, 2023 as substantially equivalent to K822686 (Denver Biomedicals, Inc., 1982) after a 122-day review. Its family tree reaches back 1 generation to 1982.

Decided
Aug 18, 2023
Review
122 days
Class
Class II
Product code
KPM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K822686 (1982). No later device cites it as a predicate yet.

Reference device: K012235 · Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber · Denver Biomedical, Inc. · 2001Reference device: K912645 · Atriums PDR Thoracic Catheter · Atrium Medical Corp. · 1991 · recalledK822686 · Denver Peritoneo-Venous Shunt (DP-VS) · Denver Biomedicals, Inc. · 198219801990200020102020
K822686 · Denver Peritoneo-Venous Shunt (DP-VS) · Denver Biomedicals, Inc. · 19820
  1. Root · 1 generation backK822686 Denver Peritoneo-Venous Shunt (DP-VS)Denver Biomedicals, Inc. · 1982
  2. This deviceK231096 Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822686Denver Peritoneo-Venous Shunt (DP-VS)Denver Biomedicals, Inc.1982—
0 (this device)K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.2023—
FIG. 1 — Lineage of K231096, 1982–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K822686Denver Peritoneo-Venous Shunt (DP-VS)
Summary page 6
…n Comparison Subject Device Predicate Device Reference Device Reference Device K231096 K822686 K012235 K912645 Denver Pleural…
Denver Biomedicals, Inc.1982—
†K012235Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedical, Inc.2001—
†K912645Atriums PDR Thoracic CatheterAtrium Medical Corp.199117

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All KPM devices

KPM Shunt, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · KPM

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPM

Too few KPM 510(k)s in any year since 2007 to give a median.

Recalls per year · KPM

No recall names KPM since 2007.

Adverse event reports per year · KPM

1in 2025

2007: 22008: 32009: 12010: 12011: 12012: 12013: 682014: 12017: 22022: 22023: 12024: 42025: 1
2007high 68 (2013) · low 0 (2015)2025

MAUDE reports naming product code KPM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—03
20090—01
20100—01
20110—01
20120—01
20130—068
20140—01
20150—00
20160—00
20171—02
20180—00
20190—00
20200—00
20210—00
20220—02
20231—01
20240—04
20250—01
20260—0—

What is it indicated for?

The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with

• chylothorax

• intractable aseptic pleural effusion

Indications for use as stated in the FDA summary.

Recent decisions in KPM

The KPM category page

  • K170405BD Curve Ascites ShuntCare Fusion · 2017
  • K012235Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedical, Inc. · 2001
  • K011862Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntDenver Biomedical, Inc. · 2001
  • K011020Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedicals, Inc. · 2001
  • K003451Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt, Denver Pak…Denver Biomedicals, Inc. · 2001

https://510kreport.com/device/K231096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231096: Automatic Continuous Effusion Shunt (ACES) System ACES System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231096

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026