510(k) · Cleared
ClearedRFG-3C Plus
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 Oct 5, 1998 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 114 later devices descend from it.
- Decided
- Oct 5, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 0
114 later devices descend from it, 4 citing it directly.
- This deviceK982489 RFG-3C PlusRadionics, Inc. · 1998
- Descendant · cites it directly · 76 of its ownK021329 Rita SystemRita Medical Systems · 2002
- Descendant · 2 generations on · 75 of its ownK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- Descendant · 3 generations on · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- Descendant · 3 generations on · 50 of its ownK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- Descendant · 4 generations on · 42 of its ownK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K021329Rita SystemRita Medical Systems · 2002 · cites it directly76descendants
- K042216Cool-Tip RF Ablation SystemValleylab · 2004 · 2 generations on75descendants
- K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 3 generations on56descendants
- K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 3 generations on50descendants
- K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982489 | RFG-3C Plus | Radionics, Inc. | 1998 | — |
| +1 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| +2 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| +3 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| +3 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| +4 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 13 | 0 |
| 2024 | 15 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (114)
See all 1144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021329 | Rita System | 2002 | 76 |
| K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman… | 2005 | 20 |
| K033981 | Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 | 2004 | 14 |
| K101592 | Erase Hand- Held Controller; Erase Single Use Electric Catridge System | 2011 | 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?
- Of its descendants, K021329 (Rita Medical Systems, 2002) has gone furthest, with 76 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 | — |
What is it indicated for?
The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is intended to create lesions in nervous tissue.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982489: RFG-3C Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982489
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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