510(k) · Cleared
ClearedSimuplan Treatment Planning System, Model V. 7.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simuplan S.L. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 17, 2003 as substantially equivalent to K983343 (Nucletron Corp., 1999) and 1 other predicate after a 187-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 17, 2003
- Review
- 187 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911612 (1991). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 1 generation backK983343 Plato Brachytheraphy, Model V. 14.0Nucletron Corp. · 1999
- This deviceK030821 Simuplan Treatment Planning System, Model V. 7.5Simuplan S.L. · 2003
- Descendant · cites it directly · 1 of its ownK093391 Simuplan Treatment Planning SystemSimuplan S.L. · 2009
- Descendant · 2 generations on · 0 of its ownK120551 Simuplan Treatment Planning SystemSimuplan S.L. · 2012
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 |
|---|---|---|---|---|---|
| −2 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −1 | K983343 | Plato Brachytheraphy, Model V. 14.0 | Nucletron Corp. | 1999 | — |
| 0 (this device) | K030821 | Simuplan Treatment Planning System, Model V. 7.5 | Simuplan S.L. | 2003 | — |
| +1 | K093391 | Simuplan Treatment Planning System | Simuplan S.L. | 2009 | — |
| +2 | K120551 | Simuplan Treatment Planning System | Simuplan S.L. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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.
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 |
|---|---|---|---|
| K093391 | Simuplan Treatment Planning System | 2009 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093391 (Simuplan S.L., 2009) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K983343.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030821: Simuplan Treatment Planning System, Model V. 7.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030821
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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