510(k) · Cleared
ClearedIsoSphere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isoaid, LLC · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 15, 2025 as substantially equivalent to K113210 (Isoaid, LLC, 2012) after a 300-day review. Its family tree reaches back 5 generations to 1980.
- Decided
- Jul 15, 2025
- Review
- 300 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801748 (1980). 18 ancestors in all. No later device cites it as a predicate yet.
- 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 backK113210 Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC · 2012
- This deviceK242818 IsoSphereIsoaid, LLC · 2025
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 | K113210 | Advantage-Strand/Advantage-Load Brachytherapy Kit | Isoaid, LLC | 2012 | — |
| 0 (this device) | K242818 | IsoSphere | Isoaid, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 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 K252296 OncoPatchscore 10.8 · 2 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 |
|---|---|---|---|
| * | K113210 | Advantage-Strand/Advantage-Load Brachytherapy KitSummary page 5…Class II Regulation Number: 21 CFR 892.5730, Radionuclide Brachytherapy Source Product Code: KXK Panel: 90-Radiology Predicate Device: K113210 - Advantage Strand/Advantage Load Brachytherapy Kit Device Description: The IsoSphere is a modification to the Advantage Strand… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 18 ancestors have a recall of any class.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
IsoSphere is indicated for implantation after tumor resection in the breast to deliver the prescribed radiation dose to the tumor bed and any residual tumor in the remaining margins.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242818: IsoSphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242818
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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