510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231096Substantially Equivalent

Automatic Continuous Effusion Shunt (ACES) System ACES System

Pleural Dynamics, Inc., Wayzata MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231096 is the FDA 510(k) clearance record for Automatic Continuous Effusion Shunt (ACES) System ACES System, a class II device, cleared for Pleural Dynamics, Inc. on under FDA product code KPM (Shunt, Peritoneal). FDA records list one 510(k) clearance for Pleural Dynamics, Inc. As of , FDA records show no recalls naming K231096.

Clearance record

Decision date
Received
(122 days to decision)
Product code
KPM Shunt, Peritoneal
Regulation
21 CFR 876.5955
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pleural Dynamics, Inc. 952 Medina Rd., Wayzata MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPM

Trailing 12 months

FDA records hold no clearances under product code KPM in the trailing twelve months.

FDA records show no clearances under product code KPM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260