Cleared Abbreviated

K131694 - NMI PORT II CATHETER (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K131694 · Navilyst Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
59d
Days
Class 2
Risk

K131694 is an FDA 510(k) clearance for the NMI PORT II CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 8, 2013 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Navilyst Medical, Inc. devices

Submission Details

510(k) Number K131694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date August 08, 2013
Days to Decision 59 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 286
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K131694.
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · Bard Access Systems, Inc. · Sep 2025
PowerPort™ isp Implantable Port
K251253 · Bard Access Systems, Inc. · Jun 2025
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
K242328 · Bard Access Systems, Inc. · Oct 2024
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737 · Bard Peripheral Vascular, Inc. · Dec 2023
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · AngioDynamics, Inc. · May 2020
Bard Power-Injectable Implantable Ports (PowerPorts®)
K181446 · C.R. Bard, Inc. · Jul 2019