510(k) · Cleared
ClearedAxxent Surface Applicator, Model 710257
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 Feb 11, 2009 as substantially equivalent to K073107 (Nucletron Corporation, 2007) after a 57-day review. Its family tree reaches back 3 generations to 1986. 3 later devices descend from it.
- Decided
- Feb 11, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK073107 Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation · 2007
- This deviceK083734 Axxent Surface Applicator, Model 710257Xoft, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK130549 Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- Descendant · 3 generations on · 0 of its ownK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
Most influential descendants
Showing 3 of 3 · See all- K130549Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc. · 2013 · cites it directly2descendants
- K162568Intrabeam 600Carl Zeiss Meditec, AG · 2016 · 2 generations on1descendant
- K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K073107 | Valencia Skin Applicator Set, Model: 189.701 | Nucletron Corporation | 2007 | — |
| 0 (this device) | K083734 | Axxent Surface Applicator, Model 710257 | Xoft, Inc. | 2009 | — |
| +1 | K130549 | Intrabeam Flat Applicator, Intrabeam Surface Applicator | Carl Zeiss Meditec, Inc. | 2013 | 1 |
| +2 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
| +3 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART… | Carl Zeiss Meditec, AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K073107 | Valencia Skin Applicator Set, Model: 189.701Summary page 1…Premarket Notification Nucletron Valencia Skin Applicator Set K073107 Page, 14 Axxent® Surface Applicator 510(k)… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130549 | Intrabeam Flat Applicator, Intrabeam Surface Applicator | 2013 | 2 |
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 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130549 (Carl Zeiss Meditec, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K073107.
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 Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including lntraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083734: Axxent Surface Applicator, Model 710257.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083734
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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