Cleared Traditional

K092205 - PALINDROME P HEMODIALYSIS CATHETER

K092205 is an FDA 510(k) clearance for PALINDROME P HEMODIALYSIS CATHETER, manufactured by Covidien Lp, Formerly Registered AS Kendall. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K092205 · Covidien Lp, Formerly Registered AS Kendall · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
100d
Days
Class 2
Risk

K092205 is an FDA 510(k) clearance for the PALINDROME P HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Registered AS Kendall (Mansfield, US). The FDA issued a Cleared decision on October 30, 2009 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Covidien Lp, Formerly Registered AS Kendall devices

FDA 510(k) Submission Details - K092205

510(k) Number K092205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 22, 2009
Decision Date October 30, 2009
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K092205.
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K110936 · AngioDynamics, Inc. · Jun 2011
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K102238 · Teleflexmedical, Inc. · Feb 2011
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K101843 · AngioDynamics, Inc. · Oct 2010
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
K090528 · C.R. Bard, Inc. · May 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · Merit Medical Systems, Inc. · Apr 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc. · Feb 2009