Cleared Traditional

K915253 - IR-192 IMPLANT, MODIFICATION

K915253 is an FDA 510(k) clearance for IR-192 IMPLANT, manufactured by Omnitron Intl., Inc.. The device is a Class 2 Radiology device with product code IWA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K915253 · Omnitron Intl., Inc. · Radiology device
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Feb 1992
Decision
101d
Days
Class 2
Risk

K915253 is an FDA 510(k) clearance for the IR-192 IMPLANT, MODIFICATION. Classified as Source, Wire, Iridium, Radioactive (product code IWA), Class II - Special Controls.

Submitted by Omnitron Intl., Inc. (Lajke Charles, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 101 days - within the typical 510(k) review window.

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 Omnitron Intl., Inc. devices

FDA 510(k) Submission Details - K915253

510(k) Number K915253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date February 27, 1992
Days to Decision 101 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
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWA Device Classification - Class 2, Special Controls

Product Code IWA Source, Wire, Iridium, Radioactive
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.