510(k) · Decided
DecidedAdjustable Multi-Catheter Source Applictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Scientific, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 9, 2006 after a 99-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK062241 Adjustable Multi-Catheter Source ApplictorNorth American Scientific, Inc. · 2006
- Descendant · cites it directly · 14 of its ownK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK081079 Contura MLB Source Applicator for BrachytherapySenorx, 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 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007 · cites it directly14descendants
- K081079Contura MLB Source Applicator for BrachytherapySenorx, 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 |
|---|---|---|---|---|---|
| 0 (this device) | K062241 | Adjustable Multi-Catheter Source Applictor | North American Scientific, Inc. | 2006 | — |
| +1 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| +2 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | 2007 | 14 |
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, K071229 (Senorx, Inc., 2007) has gone furthest, with 14 descendants of its own.
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 Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy
when the physician chooses to deliver intracavitary radiation to the surgical margins
following lumpectomy of breast cancer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062241: Adjustable Multi-Catheter Source Applictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062241
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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