510(k) · Cleared
ClearedUtrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring CT/MR Applicator Set,Model 110.330,
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 May 18, 2009 as substantially equivalent to K983341 (Nucletron Corp., 1999) after a 27-day review. Its family tree reaches back 3 generations to 1986. 4 later devices descend from it.
- Decided
- May 18, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 4 later devices descend from it, 3 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 backK983341 Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal…Nucletron Corp. · 1999
- This deviceK091154 Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270…Nucletron Corporation · 2009
- Descendant · cites it directly · 1 of its ownK201272 GenevaNucletron B.V. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250289 Intracavitary/Interstitial SystemVarian Medical Systems · 2025
- Descendant · cites it directly · 0 of its ownK180069 HDR MRI Lumen MarkerC4 Imaging, LLC · 2018
- Descendant · cites it directly · 0 of its ownK161688 Advanced Gynecological ApplicatorNucletron B.V. · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K201272GenevaNucletron B.V. · 2020 · cites it directly1descendant
- K250289Intracavitary/Interstitial SystemVarian Medical Systems · 2025 · 2 generations on0descendants
- K180069HDR MRI Lumen MarkerC4 Imaging, LLC · 2018 · cites it directly0descendants
- K161688Advanced Gynecological ApplicatorNucletron B.V. · 2017 · cites it directly0descendants
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 | K983341 | Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR… | Nucletron Corp. | 1999 | — |
| 0 (this device) | K091154 | Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270… | Nucletron Corporation | 2009 | — |
| +1 | K201272 | Geneva | Nucletron B.V. | 2020 | 1 |
| +2 | K250289 | Intracavitary/Interstitial System | Varian Medical Systems | 2025 | — |
| +1 | K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | 2018 | — |
| +1 | K161688 | Advanced Gynecological Applicator | Nucletron B.V. | 2017 | 1 |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K983341 | Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…Summary page 1…able below: FManufacturer Device 510(k)U Nucletron BV Ring CT/MR Applicator Set and Standard CT/MVR k983341 Applicator set Description: The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator… | 1999 |
What descends from it? (4)
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 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, K201272 (Nucletron B.V., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K983341.
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. 2009, 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 intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091154: Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring CT/MR Applicator Set,Model 110.330,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091154
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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