510(k) · Cleared
ClearedCesium-131 Strand, Strand Preload, Preload, S-Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isoray, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Nov 9, 2006 as substantially equivalent to K030162 (Isoray, Inc., 2003) and 6 other predicates after an 86-day review. Its family tree reaches back 5 generations to 1980. 7 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K801748 (1980). 23 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- 4 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- 3 generations backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- 2 generations backK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
- 1 generation backK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
- This deviceK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK092136 Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK180515 GammaTileIsoray Medical, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK190296 GammaTileGt Medical Technologies · 2019
- Descendant · 4 generations on · 1 of its ownK190839 GammaTileGt Medical Technologies · 2020
- Descendant · cites it directly · 1 of its ownK092458 Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131…Isoray Medical, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009 · cites it directly4descendants
- K180515GammaTileIsoray Medical, Inc. · 2018 · 2 generations on3descendants
- K190296GammaTileGt Medical Technologies · 2019 · 3 generations on2descendants
- K190839GammaTileGt Medical Technologies · 2020 · 4 generations on1descendant
- K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| −4 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| −3 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| −2 | K040339 | Brachytherapy Strand Device | Bebig Isotopen-Und Medizintechnik GmbH | 2004 | — |
| −1 | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06 | Theragenics Corp. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K180515 | GammaTile | Isoray Medical, Inc. | 2018 | — |
| +3 | K190296 | GammaTile | Gt Medical Technologies | 2019 | — |
| +4 | K190839 | GammaTile | Gt Medical Technologies | 2020 | — |
| +1 | K092458 | Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded… | Isoray Medical, Inc. | 2009 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030162 | Lawrence Cserion, Model CS-1Summary page 1…Needles C) Loose Seeds Preloaded in Needles D) Seeds in Sterile Cartridges Primary Predicate Devices: 1) K030162 Cs-131 Brachytherapy Seed, Model CS-i 2) KOI 1155 Interstrand 125 and Interstrand1 03… | 2003 |
| * | K011155 | Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S | 2001 |
| * | K030594 | I-125 Rapid Strand, Model 7000Summary page 1…ces: 1) K030162 Cs-131 Brachytherapy Seed, Model CS-i 2) KOI 1155 Interstrand 125 and Interstrand1 03 3) K(030594 1-125 Rapid Strand, Model 7000 4) K043336 Optistrand, Model 1032S 5)… | 2003 |
| * | K043336 | Optistrand, Model 1032SSummary page 1…2) KOI 1155 Interstrand 125 and Interstrand1 03 3) K(030594 1-125 Rapid Strand, Model 7000 4) K043336 Optistrand, Model 1032S 5) K(040339 Brachytherapy Strand Device 6) K(… | 2005 |
| * | K040339 | Brachytherapy Strand DeviceSummary page 1…3) K(030594 1-125 Rapid Strand, Model 7000 4) K043336 Optistrand, Model 1032S 5) K(040339 Brachytherapy Strand Device 6) K(04 1702 EZ-Pak 7) K(043596 Theraload… | 2004 |
| * | K041702 | EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) | 2004 |
| * | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06Summary page 1…d, Model 1032S 5) K(040339 Brachytherapy Strand Device 6) K(04 1702 EZ-Pak 7) K(043596 Theraload Custom Loaded Needles, Models 200 & 1 8)K1(60636 Palladium-103 SeedlImplant Preloads -Mul… | 2005 |
| Kept off the family tree | K060636 | FDA’s K060636 is Palladium-103 Seed Implant Kits -Multiple Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K092136 (Isoray Medical, Inc., 2009) has gone furthest, with 4 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.
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?
IsoRay Medical, Inc. Cesium-131 Implant Devices are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.
The Cesium-131 Implant Devices have the same indications for use as the original device, the IsoRay Medical Inc. Cs-131 Brachytherapy Seed, Model CS-I
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062384
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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