Cleared Special

K150448 - NMI PICC III and NMI PICC IV

K150448 is an FDA 510(k) clearance for NMI PICC III and NMI PICC IV, manufactured by Navilyst Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 27-day FDA review.

K150448 · Navilyst Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
27d
Days
Class 2
Risk

K150448 is an FDA 510(k) clearance for the NMI PICC III and NMI PICC IV. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on March 19, 2015 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Navilyst Medical, Inc. devices

FDA 510(k) Submission Details - K150448

510(k) Number K150448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date March 19, 2015
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 256
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K150448.
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · Navilyst Medical, Inc. · Sep 2015
C3 Wave
K143238 · Medcomp ( Medical Components) · Apr 2015
Xcela Power Injectable PICC
K150527 · Navilyst Medical, Inc. · Mar 2015
NAUTILUS DELTA
K141634 · Romedex International Srl · Jan 2015
Celerity PICC Tip Confirmation System
K142889 · AngioDynamics, Inc. · Jan 2015
Sherlock 3CG Tip Positioning System Stylet
K142267 · C.R. Bard, Inc. · Oct 2014