510(k) · Decided
DecidedRita RF Generator and Accessories, Model 500 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rita Medical Systems · GXD Generator, Lesion, Radiofrequency
Cleared on Mar 27, 2000 after a 560-day review. The FDA summary names its predicate without a number. 79 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 560 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 2 citing it directly.
- This deviceK983214 Rita RF Generator and Accessories, Model 500 SeriesRita Medical Systems · 2000
- 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 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · 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) | K983214 | Rita RF Generator and Accessories, Model 500 Series | Rita Medical Systems | 2000 | — |
| +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 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 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? (6)
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 |
|---|---|---|---|
| * | — | RITA Medical Systems Inc. — Model 500 Electrosurgical RF Generator Named without a submission number | |
| * | — | RITA Medical Systems Inc. — Models 20 and 30 Electrosurgical Accessories Named without a submission number | |
| * | — | RITA Medical Systems Inc. — Model 30F Electrosurgical Probe Named without a submission number | |
| * | — | RITA Medical Systems Inc. — Model 200C Electrosurgical Probe Named without a submission number | |
| * | — | RITA Medical Systems Inc. — Model 30-6 Electrode Array Electrosurgical Probe Named without a submission number | |
| * | — | RITA Medical Systems Inc. — Model 10P Passive Temperature Probe Accessory Named without a submission number |
What descends from it? (79)
See all 792 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 RITA System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of non-resectable liver lesions.
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/K983214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983214: Rita RF Generator and Accessories, Model 500 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983214
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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