Cleared Traditional

K131260 - NMI DIALYSIS CATHETER

K131260 is an FDA 510(k) clearance for NMI DIALYSIS CATHETER, manufactured by Navilyst Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K131260 · Navilyst Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
288d
Days
Class 2
Risk

K131260 is an FDA 510(k) clearance for the NMI DIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on February 14, 2014 after a review of 288 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 Navilyst Medical, Inc. devices

FDA 510(k) Submission Details - K131260

510(k) Number K131260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 02, 2013
Decision Date February 14, 2014
Days to Decision 288 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
157d slower than avg
Panel avg: 131d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K131260.
VECTORFLOW
K141051 · Arrow International, Inc. · Jul 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
K141363 · Merit Medical Systems, Inc. · Jun 2014
SPLIT CATH RG
K130889 · Medcomp · Apr 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
K133796 · Marvao Medical Devices, Ltd. · Jan 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · Health Line International Corporation · Jan 2014
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
K131814 · Ameco Medical Industries · Jul 2013