510(k) · Cleared
ClearedSun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun-Rain System Corp. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Oct 23, 2009 as substantially equivalent to K024013 (Sun-Rain System Corp., 2003) after a 235-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 23, 2009
- Review
- 235 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024013 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK024013 Sun-Rain Ultrasonic Therapy, SU-100Sun-Rain System Corp. · 2003
- This deviceK090542 Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600…Sun-Rain System Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024013 | Sun-Rain Ultrasonic Therapy, SU-100 | Sun-Rain System Corp. | 2003 | — |
| 0 (this device) | K090542 | Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700… | Sun-Rain System Corp. | 2009 | — |
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 IMI? 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 IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.4 · 4 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 |
|---|---|---|---|
| * | K024013 | Sun-Rain Ultrasonic Therapy, SU-100Summary page 1…N IMI, Class II CODE: REGULATION NUMBER: 890.5300 PREDICATED DEVICE: SUN-RAIN Ultrasonic Therapy, SU-100 K024013 INTENDED USE: The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the tre… | 2003 |
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?
- Its one ancestor has no recall.
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues
for the treatment of selected medical conditions such as relief of pain, muscle
spasms, and joint contractures, but not for the treatment of malignancies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090542 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090542: Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090542
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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