510(k) · Cleared
ClearedEsteya
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron B.V. · JAD System, Therapeutic, X-Ray
Cleared on Sep 26, 2013 as substantially equivalent to K122951 (Icad, Inc., 2013) and 2 other predicates after an 83-day review. Its family tree reaches back 9 generations to 1986. 1 later device descends from it.
- Decided
- Sep 26, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K864210 (1986). 22 ancestors in all, the oldest K852907 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 5 generations between
- 3 generations backK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- 2 generations backK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- 1 generation backK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- This deviceK132092 EsteyaNucletron B.V. · 2013
- Descendant · cites it directly · 0 of its ownK213942 EsteyaNucletron B.V. · 2022
Show all 9 generations
- Root · 9 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 8 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 7 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 6 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 5 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 4 generations backK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 3 generations backK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- 2 generations backK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- 1 generation backK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- This deviceK132092 EsteyaNucletron B.V. · 2013
Most influential descendants
Showing 1 of 1 · See all- K213942EsteyaNucletron B.V. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −8 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −7 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −6 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −5 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −4 | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −3 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| −2 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
| −1 | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110 | Icad, Inc. | 2013 | — |
| 0 (this device) | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| +1 | K213942 | Esteya | Nucletron B.V. | 2022 | — |
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 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110Summary page 1…evice -- 510(k) 9 1 iCAD Inc IAxnent t' Electronic Brachytherapy System K122951 LNucletron B.____! Valencia Skin Applicator Set K073107 LlTopex Inc.… | 2013 |
| * | K073107 | Valencia Skin Applicator Set, Model: 189.701Summary page 1…ent t' Electronic Brachytherapy System K122951 LNucletron B.____! Valencia Skin Applicator Set K073107 LlTopex Inc. ITopex SRT 100 Superficial Radiation Therapy System 1K063456 Device descr… | 2007 |
| * | K063456 | SRT100 Superficial Radiation Therapy SystemSummary page 1…encia Skin Applicator Set K073107 LlTopex Inc. ITopex SRT 100 Superficial Radiation Therapy System 1K063456 Device description: The Esteya Electronic Brachytherapy System is designed for High Dose Rate (HDR) brachy… | 2007 |
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 |
|---|---|---|---|
| K213942 | Esteya | 2022 | 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 27 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K213942 (Nucletron B.V., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122951.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Esteya electronic brachytherapy system is intended to deliver x-ray radiation for surface brachytherapy procedures. Typical applications include treatment for Basal Cell Carcinoma,
Squamous Cell Carcinoma. Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo
Malingna Melanoma, Keloids and Cutaneous Lymphoma (B and T cell).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132092: Esteya.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132092
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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