Cleared Traditional

K010283 - THERASEED(R) PALLADIUM-103 IMPLANT

Also marketed or referenced as:
MODEL 200

K010283 is an FDA 510(k) clearance for THERASEED PALLADIUM-103 IMPLANT, manufactured by Theragenics Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K010283 · Theragenics Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
86d
Days
Class 2
Risk

K010283 is an FDA 510(k) clearance for the THERASEED(R) PALLADIUM-103 IMPLANT. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Theragenics Corp. (Buford, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K010283

510(k) Number K010283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2001
Decision Date April 26, 2001
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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 145
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K010283.
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · Ibt, Inc. · Jul 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · Isoaid · Jul 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · Draximage, Inc. · Jun 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206 · Proxima Therapeutics, Inc. · Apr 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Apr 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
K010283 · THERASEED(R) PALLADIUM-103 IMPLANT
Download PDF FDA Summary Theragenics Corp.