Cleared Traditional

K151239 - NMI DUAL PORT II

K151239 is an FDA 510(k) clearance for NMI DUAL PORT II, manufactured by Navilyst Medical, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K151239 · Navilyst Medical, Inc. · General Hospital
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Jun 2016
Decision
392d
Days
Class 2
Risk

K151239 is an FDA 510(k) clearance for the NMI DUAL PORT II. 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 June 6, 2016 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Navilyst Medical, Inc. devices

FDA 510(k) Submission Details - K151239

510(k) Number K151239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date June 06, 2016
Days to Decision 392 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 129d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K151239.
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
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359 · C.R. Bard, Inc. · May 2016
Dignity Dual Port
K153238 · Medcomp ( Medical Components) · Mar 2016
NMI Port, NMI Port II
K153228 · Navilyst Medical, Inc. · Dec 2015