Cleared Special

K163452 - PICC Maximal Barrier Nursing Kit

K163452 is an FDA 510(k) clearance for PICC Maximal Barrier Nursing Kit, 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 56-day FDA review.

K163452 · Navilyst Medical, Inc. · General Hospital
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Feb 2017
Decision
56d
Days
Class 2
Risk

K163452 is an FDA 510(k) clearance for the PICC Maximal Barrier Nursing Kit. 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 February 3, 2017 after a review of 56 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 - K163452

510(k) Number K163452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 09, 2016
Decision Date February 03, 2017
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K163452.
CATHTONG II PICC Catheter
K172039 · L&Z Us, Inc. · Aug 2017
CATHTONG II PICC Catheter
K170486 · L&Z Us, Inc. · May 2017
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · C.R. Bard, Inc. · Apr 2017
VPS Rhythm Device with TipTracker Technology
K160925 · Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) · Dec 2016
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
Turbo-Flo PICC Sets
K161496 · Cook Incorporated · Oct 2016