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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 131d · 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 112
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K092205.
DURASPAN HEMODIALYSIS LONG-TERM CATHETER
K100169 · R4 Vascular, Inc. · Feb 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
K091506 · R4 Vascular, Inc. · Jan 2010
CENTROS CHRONIC HEMODIALYSIS CATHETER SET
K092597 · Ash Access Technology, Inc. · Nov 2009
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
K091760 · Dermaport, Inc. · Jul 2009
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