Cleared Traditional

K844248 - IR-192 IMPLANT (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844248 · Rads S.L., Inc. · Radiology device
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Apr 1985
Decision
159d
Days
Class 2
Risk

K844248 is an FDA 510(k) clearance for the IR-192 IMPLANT. Classified as Source, Wire, Iridium, Radioactive (product code IWA), Class II - Special Controls.

Submitted by Rads S.L., Inc. (Lake Charles, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 159 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 Rads S.L., Inc. devices

Submission Details

510(k) Number K844248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1984
Decision Date April 10, 1985
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 107d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.