510(k) · Decided
DecidedMammosite Multi Lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Aug 27, 2009 as substantially equivalent to K041929 (Proxima Therapeutics, Inc., 2004) and 1 other predicate after a 21-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Aug 27, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864210 (1986). 23 ancestors in all, the oldest K853912 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 7 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 6 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 5 generations backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- 4 generations backK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- 3 generations backK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- 2 generations backK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- 1 generation backK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- This deviceK092405 Mammosite Multi LumenHologic, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −7 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −6 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −5 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| −4 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| −3 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| −2 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| −1 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| 0 (this device) | K092405 | Mammosite Multi Lumen | Hologic, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Summary page 1…vices Name Manufacturer 510(k) Number MammoSite Radiation Hologic, Inc. K041929 Therapy System (RTS) SAVI Applicator Kit Cianna Medical K081677… | 2004 |
| * | K081677 | Savi Applicator KitSummary page 1…Radiation Hologic, Inc. K041929 Therapy System (RTS) SAVI Applicator Kit Cianna Medical K081677 The MammoSite ML is intended to provide brachytherapy when the physician Indications for chooses to deliver… | 2008 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K041929.
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. 2009, 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 MammoSite ML 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/K092405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092405: Mammosite Multi Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092405
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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