Cleared Traditional

K131260 - NMI DIALYSIS CATHETER

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

K131260 · Navilyst Medical, Inc. · Gastroenterology & Urology device
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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

Submission Details

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
158d slower than avg
Panel avg: 130d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K131260.
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
K151967 · Merit Medical Systems, Inc. · Apr 2016
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
K141363 · Merit Medical Systems, Inc. · Jun 2014
SPLIT CATH RG
K130889 · Medcomp · Apr 2014
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
K123196 · Covidien · Jan 2013
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
K121848 · Medical Components, Inc. · Sep 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487 · Medical Components, Inc. · Mar 2012