510(k) · Decided
DecidedAxxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoft, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jul 16, 2009 as substantially equivalent to K050843 (Xoft, Inc., 2005) after a 106-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- Jul 16, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K864210 (1986). 15 ancestors in all, the oldest K852907 (1985). 1 later device descends from it, 1 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 backK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 1 generation backK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- This deviceK090914 Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E…Xoft, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK190255 Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. · 2019 · cites it directly0descendants
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 | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −1 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| 0 (this device) | K090914 | Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E | Xoft, Inc. | 2009 | — |
| +1 | K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 JAD? 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 JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K050843 | Axxent Electronic Brachytherapy SystemSummary page 1…Premarket Notification Xoft Axxent.Balloon Applicator K050843 Paige 14 Axxent®- Balloon Applicator 510(k)… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190255 | Sensus Healthcare TVM Balloon Applicator | 2019 | 0 |
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 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K190255 (Sensus Healthcare, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050843.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Axxent Balloon Applicator is indicated for use with the Axxent Electronic
Brachytherapy System to deliver intracavity or intraoperative brachytherapy wherever the
physician chooses to deliver radiation treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090914: Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090914
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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