Cleared Traditional

K170405 - BD Curve Ascites Shunt

K170405 is an FDA 510(k) clearance for BD Curve Ascites Shunt, manufactured by Care Fusion. The device is a Class 2 Gastroenterology & Urology device with product code KPM cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K170405 · Care Fusion · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
265d
Days
Class 2
Risk

K170405 is an FDA 510(k) clearance for the BD Curve Ascites Shunt. Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 265 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K170405

510(k) Number K170405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 10, 2017
Decision Date November 02, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 131d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPM Device Classification - Class 2, Special Controls

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 Peers - KPM Shunt, Peritoneal

All 18
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K170405.
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096 · Pleural Dynamics, Inc. · Aug 2023
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K012235 · Denver Biomedical, Inc. · Oct 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · Denver Biomedical, Inc. · Jul 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · Denver Biomedicals, Inc. · Jun 2001
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
K003451 · Denver Biomedicals, Inc. · Jan 2001
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129 · Denver Biomaterials, Inc. · Mar 1998
K170405 · BD Curve Ascites Shunt
Download PDF FDA Summary Care Fusion