510(k) · Cleared
ClearedBiolucent Applicator, Model Rta-XX
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 Jul 28, 2006 as substantially equivalent to K980601 (Varian Assoc., Inc., 1998) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1986. 17 later devices descend from it.
- Decided
- Jul 28, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K864210 (1986). 8 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 2 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 1 generation backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- This deviceK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK070659 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · cites it directly13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −3 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −2 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −1 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| 0 (this device) | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…Summary page 1…Class II Predicate devices: NoviSad Rectal Applicator (Nucletron, B.V.) Wright Vaginal Cuff Applicator (K98060 1) Comfort Catheters (K032372) .A.M. Applicator (K961601… | 1998 |
| * | K032372 | Nucletron Comfort Catheter System, Model 189.007Summary page 1…ectal Applicator (Nucletron, B.V.) Wright Vaginal Cuff Applicator (K98060 1) Comfort Catheters (K032372) .A.M. Applicator (K961601) Manufacturer: BioLucent, Inc.… | 2003 |
| * | K961601 | H.a.M. ApplicatorSummary page 1…Wright Vaginal Cuff Applicator (K98060 1) Comfort Catheters (K032372) .A.M. Applicator (K961601) Manufacturer: BioLucent, Inc. 6 Journey, Suite 325… | 1996 |
| * | — | NoviSad Rectal Applicator (Nucletron, B.V.) Named without a submission number |
What descends from it? (17)
See all 173 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070659 (Biolucent, Inc., 2007) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K980601.
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.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K061241 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061241: Biolucent Applicator, Model Rta-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061241
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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