510(k) · Cleared
ClearedSystem, Applicator, Radionuclide, Remote Controlled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kobold, LLC · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jun 1, 2017 as substantially equivalent to K091230 (Photon Technologies Corporation, 2009) after a 129-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 1, 2017
- Review
- 129 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003270 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003270 Prostate Stepper Template Set, Model Part Number…Nucletron Corp. · 2000
- 1 generation backK091230 HDR Prostate Template and AccessoriesPhoton Technologies Corporation · 2009
- This deviceK170203 System, Applicator, Radionuclide, Remote ControlledKobold, LLC · 2017
- Descendant · cites it directly · 0 of its ownK201279 ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020
Most influential descendants
Showing 1 of 1 · See all- K201279ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K091230 | HDR Prostate Template and AccessoriesSummary page 4…Classification Panel: Radiology 9. Regulatory Classification: Class II 10. Predicate Device(s): HDR Prostrate Template and Accessories cleared in K091230 on August 12, 2009 11. Device Description: Kobold Prostate HDR Templates and HDR Stepper Templates: The Kobold Prosta… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201279 | ASSISTO Universal Applicator Clamping Device | 2020 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201279 (Geomed Medizin-Technik GmbH & Co. KG, 2020) 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. 2017, 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 Kobold Prostate HDR Template and Stepper Template are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.
The Stainless Steel Interstitial Needles and corresponding stylets are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.
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/K170203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170203: System, Applicator, Radionuclide, Remote Controlled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170203
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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