510(k) · Cleared
ClearedHDR Prostate Template and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photon Technologies Corporation · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Aug 12, 2009 as substantially equivalent to K003270 (Nucletron Corp., 2000) after a 107-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Aug 12, 2009
- Review
- 107 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003270 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003270 Prostate Stepper Template Set, Model Part Number…Nucletron Corp. · 2000
- This deviceK091230 HDR Prostate Template and AccessoriesPhoton Technologies Corporation · 2009
- Descendant · cites it directly · 1 of its ownK170203 System, Applicator, Radionuclide, Remote ControlledKobold, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK201279 ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020
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 |
|---|---|---|---|---|---|
| −1 | K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 | Nucletron Corp. | 2000 | — |
| 0 (this device) | K091230 | HDR Prostate Template and Accessories | Photon Technologies Corporation | 2009 | — |
| +1 | K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017 | — |
| +2 | K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067Summary page 1…ionuclide, Remote-controlled 21 CFR 892.5700, Class HI, Product Code JAQ Predicate Device: Nucletron Corporation, Prostate Stepper Template Set, K003270 Description The Photon Technologies HiDR Prostate Template and Accessories are designed to work as accessories to commercially a… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170203 | System, Applicator, Radionuclide, Remote Controlled | 2017 | 1 |
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?
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 HDR Prostate Template and Accessories are indicated for use as an accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091230: HDR Prostate Template and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091230
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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