510(k) · Cleared
ClearedOptisource, Model 1032P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Brachytherapy S.A. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 22, 2004 after a 119-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 119 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK040766 Optisource, Model 1032PInternational Brachytherapy S.A. · 2004
- Descendant · cites it directly · 1 of its ownK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · cites it directly · 1 of its ownK082159 Civastring PD-103Civatech Oncology, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK140490 Civa Sheet PD-103Civatech Oncology, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K131689Mri MarkerC4 Imaging, LLC · 2013 · cites it directly1descendant
- K082159Civastring PD-103Civatech Oncology, Inc. · 2008 · cites it directly1descendant
- K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017 · 2 generations on0descendants
- K140490Civa Sheet PD-103Civatech Oncology, Inc. · 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) | K040766 | Optisource, Model 1032P | International Brachytherapy S.A. | 2004 | — |
| +1 | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +1 | K082159 | Civastring PD-103 | Civatech Oncology, Inc. | 2008 | — |
| +2 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
| +2 | K140490 | Civa Sheet PD-103 | Civatech Oncology, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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, K131689 (C4 Imaging, LLC, 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.
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?
OptiSource103 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040766: Optisource, Model 1032P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040766
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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