510(k) · Cleared
Recalled · Class II · 2026Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4 MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron B.V. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Feb 26, 2014 as substantially equivalent to K983341 (Nucletron Corp., 1999) after a 163-day review. Its family tree reaches back 3 generations to 1986. It has been recalled once.
- Decided
- Feb 26, 2014
- Review
- 163 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK132889 Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR…Nucletron B.V. · 2014
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) | K132889 | Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded… | Nucletron B.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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…he table below: manufacturer Device 510(k) # Nucletron BV Fletcher Williamson Applicator Set IK983341 Description: The Fletcher CT/MVR Shielded Applicator Set is a modification of the Fletcher Williamson Applicator Set (K983341)… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2026 | Class II | Z-2710-2026 | Process control | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 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.
- 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. 2014, 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 Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132889: Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4 MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132889
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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