Cleared Traditional

K123196 - PALINDROME PRECISION H CHRONIC CATHETER

K123196 is the FDA 510(k) clearance for PALINDROME PRECISION H CHRONIC CATHETER by Covidien. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K123196 · Covidien · Gastroenterology & Urology device
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Jan 2013
Decision
112d
Days
Class 2
Risk

K123196 is an FDA 510(k) clearance for the PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATH.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 112 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 devices

Submission Details

510(k) Number K123196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2012
Decision Date January 31, 2013
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K123196.
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
K173805 · Marvao Medical Devices, Ltd. · Feb 2018
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
K151967 · Merit Medical Systems, Inc. · Apr 2016
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
K141363 · Merit Medical Systems, Inc. · Jun 2014
PALINDROME RT CHRONIC CATHETER
K111817 · Covidien · Aug 2011
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K111900 · Teleflexmedical, Inc. · Aug 2011
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
K111372 · Covidien · Aug 2011