510(k) · Cleared
ClearedTrapis (Transperineal Prostate Implant Simulator), Version 1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kps & Assoc., Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Nov 18, 1999 after a 275-day review. The FDA summary names no predicate by number.
- Decided
- Nov 18, 1999
- Review
- 275 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use. In summary, the software 1s designed.to provide a three-dimensional radiation dose distribution in the form of…
Read the full statement (130 words)
TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.
In summary, the software 1s designed.to provide a three-dimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided prostate boundary dictates the seed locations. A treatment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.
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/K990475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990475: Trapis (Transperineal Prostate Implant Simulator), Version 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990475
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026