510(k) · Cleared
ClearedProstate Stepper Template Set, Model Part Number 189,065,189,066,189,067
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 Dec 22, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 22, 2000
- Review
- 65 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK003270 Prostate Stepper Template Set, Model Part Number…Nucletron Corp. · 2000
- Descendant · cites it directly · 2 of its ownK091230 HDR Prostate Template and AccessoriesPhoton Technologies Corporation · 2009
- Descendant · 2 generations on · 1 of its ownK170203 System, Applicator, Radionuclide, Remote ControlledKobold, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK201279 ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091230HDR Prostate Template and AccessoriesPhoton Technologies Corporation · 2009 · cites it directly2descendants
- K170203System, Applicator, Radionuclide, Remote ControlledKobold, LLC · 2017 · 2 generations on1descendant
- K201279ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020 · 3 generations on0descendants
- K082530Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008 · cites it directly0descendants
- K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 | Nucletron Corp. | 2000 | — |
| +1 | K091230 | HDR Prostate Template and Accessories | Photon Technologies Corporation | 2009 | — |
| +2 | K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017 | — |
| +3 | K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020 | — |
| +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 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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, K091230 (Photon Technologies Corporation, 2009) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K003270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003270: Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003270
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026