Cleared Traditional

K132996 - CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS

K132996 is an FDA 510(k) clearance for CESITRX, manufactured by Isoray, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K132996 · Isoray, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
84d
Days
Class 2
Risk

K132996 is an FDA 510(k) clearance for the CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoray, Inc. (Richland, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 84 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 - K132996

510(k) Number K132996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2013
Decision Date December 17, 2013
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 140
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K132996.
ISOSEED
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MRI MARKER
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RAPID STRAND RX
K122764 · Medi-Physics, Inc. · Dec 2012