510(k) · Cleared

Cleared

Gliasite RTS

K111931510(k) SpecialCleared Aug 5, 201128-day reviewClass II21 CFR 892.5730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Isoray Medical, Inc. · KXK Source, Brachytherapy, Radionuclide

Cleared on Aug 5, 2011 as substantially equivalent to K003206 (Proxima Therapeutics, Inc., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Aug 5, 2011
Review: 28 days
Class: Class II
Product code: KXK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003206 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003206 Gliasite Radiation Therapy System (RTS), Model…Proxima Therapeutics, Inc. · 2001
This deviceK111931 Gliasite RTSIsoray Medical, Inc. · 2011
Descendant · cites it directly · 0 of its ownK132996 Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTSIsoray, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K132996Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTSIsoray, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003206	Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005	Proxima Therapeutics, Inc.	2001	—
0 (this device)	K111931	Gliasite RTS	Isoray Medical, Inc.	2011	—
+1	K132996	Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTS	Isoray, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K111931, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KXK device

#1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K003206	Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005 Summary page 1 …claimed: The modified GliaSite that is the subject of this submission is substantially equivalent to the GliaSiteRTS RTS as described in 510O(k) #K003206 (SE 04/25/2001). 3.9 Product Description: The GliaSite® RTS is a radiation therapy system…	Proxima Therapeutics, Inc.	2001	—

Also cleared against K003206: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132996	Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTS	Isoray, Inc.	2013	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K132996 (Isoray, Inc., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K003206.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KXK

2in 2025

2007high 8 (2014) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXK

158in 2020

2007high 158 (2020) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KXK

1in 2016

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXK

7in 2025

2007high 62 (2021) · low 0 (2010)2025

MAUDE reports naming product code KXK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	42	0	9
2008	1	—	1	15
2009	7	63	0	10
2010	1	—	0	0
2011	5	94	1	35
2012	3	109	1	4
2013	3	127	0	29
2014	8	96	0	13
2015	2	—	0	6
2016	4	49	1	40
2017	2	—	0	41
2018	1	—	0	28
2019	2	—	0	10
2020	3	158	0	15
2021	0	—	0	62
2022	1	—	0	26
2023	1	—	0	9
2024	0	—	0	15
2025	2	—	0	7
2026	0	—	0	—

What is it indicated for?

The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111931: Gliasite RTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111931

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026