Cleared Special

K061936 - KENDALL ARGYLE NEONATAL/PEDIATRIC PICC

K061936 is an FDA 510(k) clearance for KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, manufactured by The Kendall Company. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 30-day FDA review.

K061936 · The Kendall Company · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2006
Decision
30d
Days
Class 2
Risk

K061936 is an FDA 510(k) clearance for the KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by The Kendall Company (Mansfield, US). The FDA issued a Cleared decision on August 9, 2006 after a review of 30 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 The Kendall Company devices

FDA 510(k) Submission Details - K061936

510(k) Number K061936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date August 09, 2006
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 191
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