510(k) · Cleared
ClearedArt Brachytherapy Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Radiation Therapy, LLC · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jun 6, 2006 as substantially equivalent to K961601 (Mick Radio-Nuclear Instruments, Inc., 1996) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 6, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961601 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961601 H.a.M. ApplicatorMick Radio-Nuclear Instruments, Inc. · 1996
- 1 generation backK983338 Freiburg Flap Applicator Set, Part Number 089.095Nucletron Corp. · 1999
- This deviceK060299 Art Brachytherapy ApplicatorAdvanced Radiation Therapy, LLC · 2006
- Descendant · cites it directly · 0 of its ownK062135 Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC · 2006
Most influential descendants
Showing 1 of 1 · See all- K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961601 | H.a.M. Applicator | Mick Radio-Nuclear Instruments, Inc. | 1996 | — |
| −1 | K983338 | Freiburg Flap Applicator Set, Part Number 089.095 | Nucletron Corp. | 1999 | — |
| 0 (this device) | K060299 | Art Brachytherapy Applicator | Advanced Radiation Therapy, LLC | 2006 | — |
| +1 | K062135 | Art Shielded Breast Applicator | Advanced Radiation Therapy, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K961601 | H.a.M. ApplicatorSummary page 1…Officer 2. Device Name ART Breast Brachytherapy Applicator 3. Identification of Predicate or Legally Marketed Device Mick Nuclear - HAM Applicator - K961601 Nucletron Freiburg Flap Applicator set - K983338 Varian Medical Systems - Catheter Flap - 510(k) unknown but currentl… | 1996 |
| * | K983338 | Freiburg Flap Applicator Set, Part Number 089.095Summary page 1…apy Applicator 3. Identification of Predicate or Legally Marketed Device Mick Nuclear - HAM Applicator - K961601 Nucletron Freiburg Flap Applicator set - K983338 Varian Medical Systems - Catheter Flap - 510(k) unknown but currently advertised and believed to be legally marketed… | 1999 |
| * | — | Varian Medical Systems - Catheter Flap Named without a submission number |
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 |
|---|---|---|---|
| K062135 | Art Shielded Breast Applicator | 2006 | 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 10 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062135 (Advanced Radiation Therapy, LLC, 2006) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K961601.
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?
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use
with Nucletron remote afterloading equipment for non-invasive brachytherapy.
The applicator provides a means of positioning the HDR source on the periphery
of the breast to deliver radiation dose to the underlying tissue in areas of intact
skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060299: Art Brachytherapy Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060299
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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