Cleared Traditional

K020683 - ISOROD PD-103 IMPLANT, MODEL ATI-PD-103

K020683 is an FDA 510(k) clearance for ISOROD PD-103 IMPLANT, manufactured by Ati Medical, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K020683 · Ati Medical, Inc. · Radiology device
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Dec 2002
Decision
288d
Days
Class 2
Risk

K020683 is an FDA 510(k) clearance for the ISOROD PD-103 IMPLANT, MODEL ATI-PD-103. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Ati Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 288 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 Ati Medical, Inc. devices

FDA 510(k) Submission Details - K020683

510(k) Number K020683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date December 17, 2002
Days to Decision 288 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 107d · This submission: 288d
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 74
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K013964 · Cp Medical · Jan 2002