Cleared Special

K091261 - NMI PICC

K091261 is an FDA 510(k) clearance for NMI PICC, 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 13-day FDA review.

K091261 · Navilyst Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
13d
Days
Class 2
Risk

K091261 is an FDA 510(k) clearance for the NMI PICC. 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 May 12, 2009 after a review of 13 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.

FDA 510(k) Submission Details - K091261

510(k) Number K091261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date May 12, 2009
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 302
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K091261.
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
K091586 · Medcomp · Jul 2009
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670 · Becton, Dickinson & CO · Jul 2009
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466 · Medcomp · Jun 2009
FLOWPICC CATHETER
K083920 · Vasonova, Inc. · May 2009
PICC (CT RATED AND NON-RATED)
K083873 · Pfm Medical, Inc. · Mar 2009
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
K083763 · R4 Vascular, Inc. · Mar 2009
K091261 · NMI PICC
Download PDF FDA Summary Navilyst Medical, Inc.