Cleared Traditional

K903465 - IR-192 IMPLANT

K903465 is an FDA 510(k) clearance for IR-192 IMPLANT, manufactured by Rads S.L., Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K903465 · Rads S.L., Inc. · Radiology device
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Oct 1990
Decision
72d
Days
Class 2
Risk

K903465 is an FDA 510(k) clearance for the IR-192 IMPLANT. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Rads S.L., Inc. (Lake Charles, US). The FDA issued a Cleared decision on October 12, 1990 after a review of 72 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.

View all Rads S.L., Inc. devices

FDA 510(k) Submission Details - K903465

510(k) Number K903465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date October 12, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
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 109
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K903465.
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271 · Ml Strategies, Inc. · Oct 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · North American Scientific, Inc. · Feb 1997
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
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023 · Syncor Intl. Corp. · Aug 1985