510(k) · Cleared
Recalled · Class II · 2016Brachysource Brachytherapy Seed Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Feb 2, 2005 after a 71-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- KXK
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK043246 Brachysource Brachytherapy Seed ImplantsC.R. Bard, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK093663 Radionuclide Brachytherapy SourceC.R. Bard, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK140856 Brachysource Seed Implants with Sourcecap Bioabsorbable CapsC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK060636 Palladium-103 Seed Implant Kits -MultipleC.R. Bard, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K093663Radionuclide Brachytherapy SourceC.R. Bard, Inc. · 2009 · cites it directly1descendant
- K140856Brachysource Seed Implants with Sourcecap Bioabsorbable CapsC.R. Bard, Inc. · 2014 · 2 generations on0descendants
- K060636Palladium-103 Seed Implant Kits -MultipleC.R. Bard, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043246 | Brachysource Brachytherapy Seed Implants | C.R. Bard, Inc. | 2005 | — |
| +1 | K093663 | Radionuclide Brachytherapy Source | C.R. Bard, Inc. | 2009 | 1 |
| +2 | K140856 | Brachysource Seed Implants with Sourcecap Bioabsorbable Caps | C.R. Bard, Inc. | 2014 | — |
| +1 | K060636 | Palladium-103 Seed Implant Kits -Multiple | C.R. Bard, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | — | 1-1251 Implant Seed, STM 1251 Named without a submission number |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2016 | Class II | Z-0267-2018 | Other | Activity and quantity of seeds sent in shipments were incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093663 (C.R. Bard, Inc., 2009) 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.
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?
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043246: Brachysource Brachytherapy Seed Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043246
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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