510(k) · Decided
DecidedContura MLB Source Applicator for Brachytherapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on May 2, 2008 as substantially equivalent to K071229 (Senorx, Inc., 2007) and 1 other predicate after a 16-day review. Its family tree reaches back 7 generations to 1986. 11 later devices descend from it.
- Decided
- May 2, 2008
- Review
- 16 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K864210 (1986). 12 ancestors in all, the oldest K853912 (1986). 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 6 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 5 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 4 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 3 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 2 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 1 generation backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- This deviceK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 4 generations on · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 5 generations on · 3 of its ownK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · cites it directly9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 2 generations on8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 3 generations on5descendants
- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · 4 generations on4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −6 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −5 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −4 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −3 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −2 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −1 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| 0 (this device) | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| +1 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| +2 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +3 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +4 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +5 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K071229 | Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySummary page 1…ion regulation 21 CFR 892.5700; 90 JAQ Predicate devices SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy (K07 1229) MammoSite Radiation Therapy System (K030558) Description The Contura MLB Applicator… | 2007 |
| * | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 1…SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy (K07 1229) MammoSite Radiation Therapy System (K030558) Description The Contura MLB Applicator consists of a multi-lumen catheter connected to… | 2003 |
What descends from it? (11)
See all 112 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 22 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K091378 (Hologic, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K071229.
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. 2008, 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 Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide
brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins
following lumpectomy for breast cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081079: Contura MLB Source Applicator for Brachytherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081079
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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