Cleared Traditional

K123292 - T3

K123292 is the FDA 510(k) clearance for T3 by Medcomp. It is a Class 2 Gastroenterology & Urology device (product code NIE) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K123292 · Medcomp · Gastroenterology & Urology device
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Jun 2013
Decision
232d
Days
Class 2
Risk

K123292 is an FDA 510(k) clearance for the T3. Classified as Catheter, Hemodialysis, Triple Lumen, Non-implanted (product code NIE), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on June 11, 2013 after a review of 232 days - an extended review cycle.

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 Medcomp devices

Submission Details

510(k) Number K123292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2012
Decision Date June 11, 2013
Days to Decision 232 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
102d slower than avg
Panel avg: 130d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIE Catheter, Hemodialysis, Triple Lumen, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.
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 - NIE Catheter, Hemodialysis, Triple Lumen, Non-implanted

All 7
Devices cleared under the same product code (NIE) and FDA review panel - the closest regulatory comparables to K123292.
12F Tri-Flow Triple Lumen Catheter
K181175 · Medical Components, Inc. (dba MedComp) · Jul 2018
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531 · C.R. Bard, Inc. · Jun 2015
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456 · C.R. Bard, Inc. · Sep 2014
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · C.R. Bard, Inc. · Mar 2009