510(k) · Cleared
ClearedRadioactive Seed Localization Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocompatibles, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Oct 18, 2011 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 18, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK111979 Radioactive Seed Localization NeedleBiocompatibles, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK122704 Best Localization Needle with I-125 SeedBest Medical Intl. · 2013
- Descendant · cites it directly · 0 of its ownK141701 I-125 RSLN [Radioactive Seed and Localization Needle]Isoaid, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK142668 Lesion-Loc Iodine I-125 Seed/NeedleIntramedical Imaging, LLC · 2014
Most influential descendants
Showing 3 of 3 · See all- K122704Best Localization Needle with I-125 SeedBest Medical Intl. · 2013 · cites it directly1descendant
- K141701I-125 RSLN [Radioactive Seed and Localization Needle]Isoaid, LLC · 2014 · cites it directly0descendants
- K142668Lesion-Loc Iodine I-125 Seed/NeedleIntramedical Imaging, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111979 | Radioactive Seed Localization Needle | Biocompatibles, Inc. | 2011 | — |
| +1 | K122704 | Best Localization Needle with I-125 Seed | Best Medical Intl. | 2013 | — |
| +1 | K141701 | I-125 RSLN [Radioactive Seed and Localization Needle] | Isoaid, LLC | 2014 | — |
| +2 | K142668 | Lesion-Loc Iodine I-125 Seed/Needle | Intramedical Imaging, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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?
- Of its descendants, K122704 (Best Medical Intl., 2013) has gone furthest, with 1 descendant 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. 2011, 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?
The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision with the use of radioactive seeds
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111979: Radioactive Seed Localization Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111979
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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