510(k) · Decided
DecidedBiolucent Applicator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolucent, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 4, 2007 as substantially equivalent to K062830 (Biolucent, Inc., 2006) and 4 other predicates after a 26-day review. Its family tree reaches back 5 generations to 1986. 13 later devices descend from it.
- Decided
- Apr 4, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K864210 (1986). 13 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 3 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 2 generations backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- 1 generation backK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- This deviceK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 3 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- Descendant · 4 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · cites it directly12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on11descendants
- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 3 generations on9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 4 generations on8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −4 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −3 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −2 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| −1 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| 0 (this device) | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +1 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +2 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +3 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| +4 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +5 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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 |
|---|---|---|---|
| * | K062830 | Biolucent Applicator KitSummary page 1…(JAQ), 21 CFR, 892.5700 Device Classification: Class II Predicate devices: BioLucent Applicator (K(062830, K(061241) Wright Vaginal Cuff Applicator (1K980601) Comf… | 2006 |
| * | K061241 | Biolucent Applicator, Model Rta-XXSummary page 1…21 CFR, 892.5700 Device Classification: Class II Predicate devices: BioLucent Applicator (K(062830, K(061241) Wright Vaginal Cuff Applicator (1K980601) Comfort Cathet… | 2006 |
| * | K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…Summary page 1…Class II Predicate devices: BioLucent Applicator (K(062830, K(061241) Wright Vaginal Cuff Applicator (1K980601) Comfort Catheters (1(032372) Shielded Rectal Applicator… | 1998 |
| * | K032372 | Nucletron Comfort Catheter System, Model 189.007Summary page 1…nt Applicator (K(062830, K(061241) Wright Vaginal Cuff Applicator (1K980601) Comfort Catheters (1(032372) Shielded Rectal Applicator Set (K(033371) Manufacturer: BioLucent, I… | 2003 |
| * | K033371 | Varian Intracavitary Brachytherapy ApplicatorsSummary page 1…Vaginal Cuff Applicator (1K980601) Comfort Catheters (1(032372) Shielded Rectal Applicator Set (K(033371) Manufacturer: BioLucent, Inc. 6 Journey, Suite 325… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080565 | Modification to: Savi Applicator Kit | 2008 | 12 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K080565 (Cianna Medical, Inc., 2008) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K062830.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The BioLucent Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070659: Biolucent Applicator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070659
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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