Cleared Traditional

K183219 - Trio-CT Triple Lumen Catheter

K183219 is an FDA 510(k) clearance for Trio-CT Triple Lumen Catheter, manufactured by Medical Components, Inc. (dba MedComp). The device is a Class 2 Gastroenterology & Urology device with product code NIE cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K183219 · Medical Components, Inc. (dba MedComp) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
206d
Days
Class 2
Risk

K183219 is an FDA 510(k) clearance for the Trio-CT Triple Lumen Catheter. Classified as Catheter, Hemodialysis, Triple Lumen, Non-implanted (product code NIE), Class II - Special Controls.

Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on June 14, 2019 after a review of 206 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 Medical Components, Inc. (dba MedComp) devices

FDA 510(k) Submission Details - K183219

510(k) Number K183219 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 20, 2018
Decision Date June 14, 2019
Days to Decision 206 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 130d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NIE Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (NIE) and FDA review panel - the closest regulatory comparables to K183219.
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
K232945 · Medical Components, Inc. (dba MedComp) · Nov 2023
Power Acute Triple Lumen Hemodialysis Catheter
K222170 · Health Line International Corporation · Jan 2023
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
T3
K123292 · Medcomp · Jun 2013