510(k) · Cleared
ClearedGammaTile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isoray Medical, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 6, 2018 as substantially equivalent to K092136 (Isoray Medical, Inc., 2009) after a 129-day review. Its family tree reaches back 7 generations to 1980. 3 later devices descend from it.
- Decided
- Jul 6, 2018
- Review
- 129 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801748 (1980). 25 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- 6 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- 5 generations backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- 4 generations backK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
- 3 generations backK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
- 2 generations backK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
- 1 generation backK092136 Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009
- This deviceK180515 GammaTileIsoray Medical, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK190296 GammaTileGt Medical Technologies · 2019
- Descendant · 2 generations on · 1 of its ownK190839 GammaTileGt Medical Technologies · 2020
- Descendant · 3 generations on · 0 of its ownK221539 GammaTileGt Medical Technologies · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| −6 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| −5 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| −4 | K040339 | Brachytherapy Strand Device | Bebig Isotopen-Und Medizintechnik GmbH | 2004 | — |
| −3 | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06 | Theragenics Corp. | 2005 | — |
| −2 | K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | Isoray, Inc. | 2006 | — |
| −1 | K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 | Isoray Medical, Inc. | 2009 | — |
| 0 (this device) | K180515 | GammaTile | Isoray Medical, Inc. | 2018 | — |
| +1 | K190296 | GammaTile | Gt Medical Technologies | 2019 | — |
| +2 | K190839 | GammaTile | Gt Medical Technologies | 2020 | — |
| +3 | K221539 | GammaTile | Gt Medical Technologies | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Summary page 4…ially equivalent to the Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands as described in 510(k) K092136 (SE 08/07/2009). 3.8 Product Description: The GammaTile™ is a device, intended for the treatment of recurrent… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190296 | GammaTile | 2019 | 2 |
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?
- The line of descent spans 38 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K190296 (Gt Medical Technologies, 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 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?
GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180515: GammaTile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180515
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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