510(k) · Cleared
ClearedCuray Custom Seed Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolucent, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Feb 28, 2006 as substantially equivalent to K043596 (Theragenics Corp., 2005) and 3 other predicates after a 67-day review. Its family tree reaches back 5 generations to 1980.
- Decided
- Feb 28, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K801748 (1980). 19 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 backK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
- This deviceK053595 Curay Custom Seed ArrayBiolucent, Inc. · 2006
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 | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06 | Theragenics Corp. | 2005 | — |
| 0 (this device) | K053595 | Curay Custom Seed Array | Biolucent, Inc. | 2006 | — |
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 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06Summary page 1…rapy Source (KIXK), 21 CFR, 892.5730 Device Classification: Class II Predicate devices: TheraLoad (K043 596) SeedLink (K023073) Readi-Strand (K023 179)… | 2005 |
| * | K023073 | Seed LinkSummary page 1…21 CFR, 892.5730 Device Classification: Class II Predicate devices: TheraLoad (K043 596) SeedLink (K023073) Readi-Strand (K023 179) RAPID-Strand (K03 0594)… | 2003 |
| * | K023179 | Readi-Strand, Model PsstrandSummary page 1…II Predicate devices: TheraLoad (K043 596) SeedLink (K023073) Readi-Strand (K023 179) RAPID-Strand (K03 0594) Nag Brachyflex Catheters (Cook… | 2003 |
| * | K030594 | I-125 Rapid Strand, Model 7000Summary page 1…) SeedLink (K023073) Readi-Strand (K023 179) RAPID-Strand (K03 0594) Nag Brachyflex Catheters (Cook, Inc.) Manufacturer: BioLucent, Inc… | 2003 |
| * | — | Nag Brachyflex Catheters (Cook, Inc.) Named without a submission number |
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K043596.
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?
CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used 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/K053595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053595: Curay Custom Seed Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053595
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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