Cleared Special

K111931 - GLIASITE RTS

K111931 is the FDA 510(k) clearance for GLIASITE RTS by Isoray Medical, Inc.. It is a Class 2 Radiology device (product code KXK) cleared through the Special 510(k) pathway after a 28-day FDA review.

K111931 · Isoray Medical, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
28d
Days
Class 2
Risk

K111931 is an FDA 510(k) clearance for the GLIASITE RTS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on August 5, 2011 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Isoray Medical, Inc. devices

Submission Details

510(k) Number K111931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date August 05, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 19
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K111931.
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K093663 · C.R. Bard, Inc. · Dec 2009
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K060636 · C.R. Bard, Inc. · Apr 2006
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005