Cleared Traditional

K133456 - POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER

K133456 is an FDA 510(k) clearance for POWER-TRIALYSIS SHORT-TERM DIALYSIS CAT..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NIE cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K133456 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
316d
Days
Class 2
Risk

K133456 is an FDA 510(k) clearance for the POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Triple Lumen, Non-implanted (product code NIE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 24, 2014 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K133456

510(k) Number K133456 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 12, 2013
Decision Date September 24, 2014
Days to Decision 316 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
185d slower than avg
Panel avg: 131d · This submission: 316d
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 9
Devices cleared under the same product code (NIE) and FDA review panel - the closest regulatory comparables to K133456.
12F Tri-Flow Triple Lumen Catheter
K181175 · Medical Components, Inc. (dba MedComp) · Jul 2018
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
K143102 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Jul 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531 · C.R. Bard, Inc. · Jun 2015
T3
K123292 · Medcomp · Jun 2013
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · C.R. Bard, Inc. · Mar 2009
MEDCOMP T-3
K033570 · Medcomp · Sep 2004