510(k) · Cleared
ClearedMU Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rad Therapy Solutions, Inc. · IYE Accelerator, Linear, Medical
Cleared on Feb 10, 2000 as substantially equivalent to K914698 (K.S., Inc., 1992) and 1 other predicate after a 184-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Feb 10, 2000
- Review
- 184 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862643 (1987). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 2 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 1 generation backK980379 Prowess Pro-SimSsgi Prowess Systems · 1998
- This deviceK992689 MU PlusRad Therapy Solutions, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −2 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −1 | K980379 | Prowess Pro-Sim | Ssgi Prowess Systems | 1998 | — |
| 0 (this device) | K992689 | MU Plus | Rad Therapy Solutions, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1996 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K914698 | Setup Computer with Software V-1261,62 and 63Summary page 1…ication Name: Medical Charged Particle Radiation Therapy System (Accessory) 21 CFR 892.5050 (class II) Substantial Equivalence: K&S Associates, PC Setup Program 510(k) K914698 SSGI, Prowess Pro-Sim 510(k) K980379 Description: The MU Plus! monitor unit calculation verification program is designed to op… | 1992 |
| * | K980379 | Prowess Pro-SimSummary page 1…Radiation Therapy System (Accessory) 21 CFR 892.5050 (class II) Substantial Equivalence: K&S Associates, PC Setup Program 510(k) K914698 SSGI, Prowess Pro-Sim 510(k) K980379 Description: The MU Plus! monitor unit calculation verification program is designed to operate on an IBM compatible personal co… | 1998 |
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.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K914698.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
MU Plus! is a quality assurance tool for monitor unit calculations performed in radiation oncology clinics. MU Plus! is designed to be used as a verification of treatment planning derived monitor unit settings or hand generated monitor unit settings. Monitor unit calculations for linear accelerators are performed by various staff of radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists. MU Plus! also contains a diode measurement verification program which predicts an expected diode reading based on a formalism similar to the monitor unit calculations.
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/K992689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992689: MU Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992689
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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