Cleared Traditional

K183219 - Trio-CT Triple Lumen Catheter (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183219 · Medical Components, Inc. (dba MedComp) · Gastroenterology & Urology device
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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

Submission Details

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
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.

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.