510(k) · Cleared
ClearedModel RFG-3C Radiofrequency Lesion Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Apr 8, 1991 after a 371-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 8, 1991
- Review
- 371 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK901540 Model RFG-3C Radiofrequency Lesion GeneratorRadionics, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK042096 Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK070779 Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK150019 TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc. · 2006 · cites it directly2descendants
- K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008 · 2 generations on1descendant
- K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901540 | Model RFG-3C Radiofrequency Lesion Generator | Radionics, Inc. | 1991 | — |
| +1 | K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System | Misonix, Inc. | 2006 | — |
| +2 | K070779 | Sonatherm 600I Ultrasonic Lesion Generating System | Misonix, Inc. | 2008 | — |
| +3 | K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXD? 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 GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System | 2006 | 2 |
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?
- Of its descendants, K042096 (Misonix, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, 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 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K901540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K901540: Model RFG-3C Radiofrequency Lesion Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901540
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026