510(k) · Cleared
ClearedValencia Skin Applicator Set, Model: 189.701
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corporation · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Dec 7, 2007 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) after a 35-day review. Its family tree reaches back 2 generations to 1986. 7 later devices descend from it.
- Decided
- Dec 7, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK073107 Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation · 2007
- Descendant · cites it directly · 3 of its ownK083734 Axxent Surface Applicator, Model 710257Xoft, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK130549 Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- Descendant · cites it directly · 1 of its ownK132092 EsteyaNucletron B.V. · 2013
- Descendant · 4 generations on · 0 of its ownK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K083734Axxent Surface Applicator, Model 710257Xoft, Inc. · 2009 · cites it directly3descendants
- K130549Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc. · 2013 · 2 generations on2descendants
- K162568Intrabeam 600Carl Zeiss Meditec, AG · 2016 · 3 generations on1descendant
- K132092EsteyaNucletron B.V. · 2013 · cites it directly1descendant
- K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K073107 | Valencia Skin Applicator Set, Model: 189.701 | Nucletron Corporation | 2007 | — |
| +1 | K083734 | Axxent Surface Applicator, Model 710257 | Xoft, Inc. | 2009 | — |
| +2 | K130549 | Intrabeam Flat Applicator, Intrabeam Surface Applicator | Carl Zeiss Meditec, Inc. | 2013 | 1 |
| +3 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
| +1 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| +4 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K953946 | Microselectron-HDR Version 2Summary page 2…Summary of technological considerations: The Valencia Skin Applicator Set is substantially equivalent to the cleared predicate device, Leipzig Applicator Set, 510(k)#: K953946. -/ -o… | 1996 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083734 (Xoft, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 27 other devices also cite its predicate K953946.
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. 2007, 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 Valencia Skin Applicator Set is intended for surface Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073107: Valencia Skin Applicator Set, Model: 189.701.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073107
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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