510(k) · Cleared
ClearedImplant Guidance System Applicator Set
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 Mar 13, 2002 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) after a 69-day review. Its family tree reaches back 2 generations to 1986. 20 later devices descend from it.
- Decided
- Mar 13, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- Descendant · cites it directly · 19 of its ownK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- Descendant · 2 generations on · 17 of its ownK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · 3 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K032372Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003 · cites it directly19descendants
- K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006 · 2 generations on17descendants
- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · 2 generations on13descendants
- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 3 generations on12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| +1 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| +2 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| +2 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +3 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +2 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K953946 | Microselectron-HDR Version 2Summary page 1…ly Marketed Device(s) Our device is substantially equivalent to the legally marketed predicate device cited in the table_ below “Nu:cletron'B\‘/‘ Spetser Needle Set | :K953946 — Nucletron B.V. Flexible Implant Tubes K953946 Nucletron B.V. Interstitial Needle Set K953946 Description: The Nucletron Impla… | 1996 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032372 | Nucletron Comfort Catheter System, Model 189.007 | 2003 | 19 |
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 16 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032372 (Nucletron Corporation, 2003) has gone furthest, with 19 descendants of its own.
- 27 other devices also cite its predicate K953946.
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 Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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/K020015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020015: Implant Guidance System Applicator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020015
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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