Cleared Special

K041576 - SOURCELINK

K041576 is the FDA 510(k) clearance for SOURCELINK by C.R. Bard, Inc.. It is a Class 2 Radiology device (product code KXK) cleared through the Special 510(k) pathway after a 21-day FDA review.

K041576 · C.R. Bard, Inc. · Radiology device
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Jul 2004
Decision
21d
Days
Class 2
Risk

K041576 is an FDA 510(k) clearance for the SOURCELINK. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K041576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2004
Decision Date July 02, 2004
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 29
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K041576.
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550 · Cp Medical · Jul 2007
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · C.R. Bard, Inc. · Apr 2006
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
CP SLEEVE AND RIVER SLEEVE
K034062 · Cp Medical · Jan 2004
VARISEED 7.1
K030534 · Varian Medical Systems · May 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003