510(k) · Cleared
Recalled · Class II · 2018Radionuclide Brachytherapy Source
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 Dec 23, 2009 as substantially equivalent to K043246 (C.R. Bard, Inc., 2005) after a 28-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 23, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- KXK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043246 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK043246 Brachysource Brachytherapy Seed ImplantsC.R. Bard, Inc. · 2005 · Recalled
- This deviceK093663 Radionuclide Brachytherapy SourceC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK140856 Brachysource Seed Implants with Sourcecap Bioabsorbable CapsC.R. Bard, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140856Brachysource Seed Implants with Sourcecap Bioabsorbable CapsC.R. Bard, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043246 | Brachysource Brachytherapy Seed Implants | C.R. Bard, Inc. | 2005 | 1 |
| 0 (this device) | K093663 | Radionuclide Brachytherapy Source | C.R. Bard, Inc. | 2009 | — |
| +1 | K140856 | Brachysource Seed Implants with Sourcecap Bioabsorbable Caps | C.R. Bard, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K043246 | Brachysource Brachytherapy Seed ImplantsSummary page 1…CE NAME: Trade Names: BrachySourcee Brachytherapy Seed Implants K043246 D. DEVICE DESCRIPTION:, BrachySourceo Seed Implants consist of a we… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140856 | Brachysource Seed Implants with Sourcecap Bioabsorbable Caps | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2018 | Class II | Z-1702-2018 | Labeling mix-ups | Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
BrachySourcee Seed Implant's are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck,. lung, pancreas, and early stage prostate. Br achySource® 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/K093663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093663: Radionuclide Brachytherapy Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093663
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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