Cleared Traditional

K062214 - BRACHYSCIENCES STRANDPORT

K062214 is an FDA 510(k) clearance for BRACHYSCIENCES STRANDPORT, manufactured by Worldwide Medical Technologies, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K062214 · Worldwide Medical Technologies, LLC · Radiology device
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Mar 2007
Decision
212d
Days
Class 2
Risk

K062214 is an FDA 510(k) clearance for the BRACHYSCIENCES STRANDPORT. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Worldwide Medical Technologies, LLC (Oxford, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 212 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K062214

510(k) Number K062214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date March 01, 2007
Days to Decision 212 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 107d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K062214.
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · Riverpoint Medical · Feb 2011
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009
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
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004