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 Jan 11, 2022 as substantially equivalent to K132092 (Nucletron B.V., 2013) and 1 other predicate after a 25-day review. Its family tree reaches back 10 generations to 1986.
- Decided
- Jan 11, 2022
- Review
- 25 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864210 (1986). 26 ancestors in all, the oldest K852907 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 6 generations between
- 3 generations backK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- 2 generations backK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- 1 generation backK132092 EsteyaNucletron B.V. · 2013
- This deviceK213942 EsteyaNucletron B.V. · 2022
Show all 10 generations
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 9 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 8 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 7 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 6 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 5 generations backK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 4 generations backK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- 3 generations backK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- 2 generations backK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- 1 generation backK132092 EsteyaNucletron B.V. · 2013
- This deviceK213942 EsteyaNucletron B.V. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −9 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −8 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −7 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −6 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −5 | K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −4 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| −3 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
| −2 | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110 | Icad, Inc. | 2013 | — |
| −1 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| 0 (this device) | 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 |
| 2013 | 2 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K132092 | EsteyaSummary page 4…Regulation Description: X-ray radiation therapy system Product Code: JAD III. PREDICATE DEVICES Primary Predicate: K132092 – Esteya Electronic Brachytherapy System Secondary Predicate: K150037 – Sensus Healthcare Superficial X-ray Radiation Ther… | 2013 |
| * | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…Summary page 4…Product Code: JAD III. PREDICATE DEVICES Primary Predicate: K132092 – Esteya Electronic Brachytherapy System Secondary Predicate: K150037 – Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (SRT-100 Vision) IV.… | 2015 |
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 36 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 26 ancestors have a recall of any class.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 is intended to deliver X-ray radiation for superficial radiotherapy procedures and
surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell
Carcinoma, Kaposi’s Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna
Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213942 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213942: Esteya.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213942
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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