Cleared Traditional

K002429 - SELECT SEED I-125

K002429 is an FDA 510(k) clearance for SELECT SEED I-125, manufactured by Nucletron Corp.. The device is a Class 2 Radiology device width product code KXK cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K002429 · Nucletron Corp. · Radiology device
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Feb 2001
Decision
178d
Days
Class 2
Risk

K002429 is an FDA 510(k) clearance for the SELECT SEED I-125. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on February 2, 2001 after a review of 178 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 Nucletron Corp. devices

Submission Details

510(k) Number K002429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2000
Decision Date February 02, 2001
Days to Decision 178 days
Submission Type Traditional
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
71d slower than avg
Panel avg: 107d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 31
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K002429.
CP-SLEEVE
K013975 · Cp Medical · Feb 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · Cp Medical · Jan 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · Syncor Intl. Corp. · Aug 1985