Cleared Abbreviated

K042461 - KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONAT...

K042461 is an FDA 510(k) clearance for KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONAT..., manufactured by Kendall. The device is a Class 2 General Hospital device with product code LJS cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K042461 · Kendall · General Hospital
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Dec 2004
Decision
91d
Days
Class 2
Risk

K042461 is an FDA 510(k) clearance for the KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Kendall devices

FDA 510(k) Submission Details - K042461

510(k) Number K042461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2004
Decision Date December 10, 2004
Days to Decision 91 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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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PREMICATH, 1261.205
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