510(k) · Cleared
ClearedOncentra Prostate 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 18, 2011 as substantially equivalent to K022741 (Nucletron Corporation, 2002) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Nov 18, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911612 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 3 generations backK992303 Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000
- 2 generations backK022739 Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model…Nucletron Corporation · 2002
- 1 generation backK031158 Swift 2.0, Model 132.001Nucletron Corp. · 2003
- This deviceK112420 Oncentra Prostate 4.0Nucletron · 2011
- Descendant · cites it directly · 0 of its ownK170841 BiopSee, Mobile USMedcom GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K170841BiopSee, Mobile USMedcom GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −3 | K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron Corp. | 2000 | — |
| −2 | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 | Nucletron Corporation | 2002 | — |
| −1 | K031158 | Swift 2.0, Model 132.001 | Nucletron Corp. | 2003 | — |
| 0 (this device) | K112420 | Oncentra Prostate 4.0 | Nucletron | 2011 | — |
| +1 | K170841 | BiopSee, Mobile US | Medcom GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K022741 | Spot Pro (220V), Model 131.099Summary page 1…in the table below: ~ ~+A~eieett~tY~21~ ~I~50(k) U Nulern V Spot Pro K022741 Nulern V Swift 2.0 K031158 Traditional 51 0(k)… | 2002 |
| * | K031158 | Swift 2.0, Model 132.001Summary page 1…~I~50(k) U Nulern V Spot Pro K022741 Nulern V Swift 2.0 K031158 Traditional 51 0(k) Page 33 Nucletron Onc… | 2003 |
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 |
|---|---|---|---|
| K170841 | BiopSee, Mobile US | 2017 | 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 20 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K170841 (Medcom GmbH, 2017) 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. 2011, 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?
Oncentra Prostate is a software application intended for use with Brachytherapy. procedures, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources The software should only be used by a person trained in brachytherapy techniques (such a person will be referred to as the user).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112420: Oncentra Prostate 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112420
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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