Cleared Special

K111931 - GLIASITE RTS

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

K111931 · Isoray Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K111931

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K111931.
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
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K103449 · Riverpoint Medical · Feb 2011
I-SEED
K103319 · Theragenics Corp. · Jan 2011
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009