510(k) · Cleared
ClearedMsi Model S-500 RF Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsphere International, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 2, 2004 as substantially equivalent to K963772 (Somnus Medical Technologies, Inc., 1996) after a 108-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Apr 2, 2004
- Review
- 108 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963772 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963772 Somnus Model 225 Electro Surgical Generator (Model 225)Somnus Medical Technologies, Inc. · 1996
- This deviceK033888 Msi Model S-500 RF GeneratorMedsphere International, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK041980 Msi S-500L RF GeneratorMedsphere International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041980Msi S-500L RF GeneratorMedsphere International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963772 | Somnus Model 225 Electro Surgical Generator (Model 225) | Somnus Medical Technologies, Inc. | 1996 | — |
| 0 (this device) | K033888 | Msi Model S-500 RF Generator | Medsphere International, Inc. | 2004 | — |
| +1 | K041980 | Msi S-500L RF Generator | Medsphere International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K963772 | Somnus Model 225 Electro Surgical Generator (Model 225)Summary page 1…ification Name: Electrosurgical cutting and coagulation device (21CFR878.4400) Predicate Devices: Somnus Model 225 Electro Surgical Generator (K963772) Description: MSI S-500 RF Generator Statement of Intended Use: MSI S-50… | 1996 |
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 |
|---|---|---|---|
| K041980 | Msi S-500L RF Generator | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K041980 (Medsphere International, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033888: Msi Model S-500 RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033888
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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