Cleared Abbreviated

K122767 - NMI PORT

K122767 is an FDA 510(k) clearance for NMI PORT, manufactured by Navilyst Medical, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Abbreviated 510(k) pathway after a 232-day FDA review.

K122767 · Navilyst Medical, Inc. · General Hospital
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Apr 2013
Decision
232d
Days
Class 2
Risk

K122767 is an FDA 510(k) clearance for the NMI PORT. 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 April 30, 2013 after a review of 232 days - an extended review 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

FDA 510(k) Submission Details - K122767

510(k) Number K122767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2012
Decision Date April 30, 2013
Days to Decision 232 days
Submission Type Abbreviated
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
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

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 K122767.
NMI PORT II CATHETER
K131694 · Navilyst Medical, Inc. · Aug 2013
5F DIGNITY CT TITANIUM PORT
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LPP (LOW PROFILE PORT)
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CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
K130576 · B. Braun Interventional Systems, Inc. · Apr 2013
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · C.R. Bard, Inc. · Nov 2012
DIGNITY POWER INJECTABLE TITANIUM PORT
K120281 · Medical Components, Inc. · Sep 2012