510(k) · Cleared
ClearedFreiburg Flap Applicator Set, Part Number 089.095
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 Apr 20, 1999 as substantially equivalent to K961601 (Mick Radio-Nuclear Instruments, Inc., 1996) after a 209-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Apr 20, 1999
- Review
- 209 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961601 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961601 H.a.M. ApplicatorMick Radio-Nuclear Instruments, Inc. · 1996
- This deviceK983338 Freiburg Flap Applicator Set, Part Number 089.095Nucletron Corp. · 1999
- Descendant · cites it directly · 1 of its ownK060299 Art Brachytherapy ApplicatorAdvanced Radiation Therapy, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK062135 Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC · 2006
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 | K961601 | H.a.M. Applicator | Mick Radio-Nuclear Instruments, Inc. | 1996 | — |
| 0 (this device) | K983338 | Freiburg Flap Applicator Set, Part Number 089.095 | Nucletron Corp. | 1999 | — |
| +1 | K060299 | Art Brachytherapy Applicator | Advanced Radiation Therapy, LLC | 2006 | — |
| +2 | K062135 | Art Shielded Breast Applicator | Advanced Radiation Therapy, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K961601 | H.a.M. ApplicatorSummary page 1…ubstantially equivalent to the legally marketed predicate device cited in the table below: Manufacturer Device 510(k) # Mick Radio-Nuclear Instruments H.A.M. Applicator K961601 d. Description The Nucletron Freiburg Flap Applicator as described in this submission is designed as an accessory to the Nuclet… | 1996 |
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 |
|---|---|---|---|
| K060299 | Art Brachytherapy Applicator | 2006 | 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.
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 Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR. 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/K983338 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983338: Freiburg Flap Applicator Set, Part Number 089.095.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983338
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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