510(k) · Cleared
ClearedCet Prostate Applicator Set, Part Number 089.066
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Oct 7, 1999 after a 197-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Oct 7, 1999
- Review
- 197 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 2 citing it directly.
- This deviceK990990 Cet Prostate Applicator Set, Part Number 089.066Nucletron Corp. · 1999
- Descendant · cites it directly · 0 of its ownK082530 Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008
- Descendant · cites it directly · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990990 | Cet Prostate Applicator Set, Part Number 089.066 | Nucletron Corp. | 1999 | — |
| +1 | K082530 | Applicators for Afterloading Brachytherapy | Isodose Control B.V. | 2008 | — |
| +1 | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K953948 | FDA’s K953948 is Spirovision SV-Iii PC Based Spirometer Kit Micro Our OCR of the scanned summary read K953948, FDA’s number for Spirovision SV-Iii PC Based Spirometer Kit Micro (Futuremed America, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Porter Perineal Applicator Set”. Kept off the family tree. Summary page 1…s substantially equivalent to the legally marketed predicate device cited in the table below: Manufacturer Device 510(k) # Nucletron BV Porter Perineal Applicator Set © K9539486 d. Description The Nucletron CET Prostate Applicator as described in this submission is designed as an accessory to the Nuclet… | 1996 |
What descends from it? (2)
2 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?
- Of its descendants, K082530 (Isodose Control B.V., 2008) has gone furthest, with 0 descendants of its own.
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.
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?
Nucletron CET Prostate Applicator Set is intended for use with Interstitial Prostate brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990990 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990990: Cet Prostate Applicator Set, Part Number 089.066.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990990
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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