Cleared Traditional

K023210 - SEEDLINKS, MODELS 70301, 70302, 70303

K023210 is an FDA 510(k) clearance for SEEDLINKS, manufactured by Sourcetech Medical, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K023210 · Sourcetech Medical, LLC · Radiology device
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Mar 2003
Decision
183d
Days
Class 2
Risk

K023210 is an FDA 510(k) clearance for the SEEDLINKS, MODELS 70301, 70302, 70303. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Sourcetech Medical, LLC (Carol Stream, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 183 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.

FDA 510(k) Submission Details - K023210

510(k) Number K023210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2002
Decision Date March 28, 2003
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
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 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K023210.
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K030745 · Varian Medical Systems · Mar 2003
K023210 · SEEDLINKS, MODELS 70301, 70302, 70303
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