510(k) · Cleared
Recalled · Class II · 2014Rita Model 90 Electrosurgical Accessory, Model 90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rita Medical Systems · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 10, 1999 after a 29-day review. The FDA summary names its predicate without a number. 77 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 10, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 0
77 later devices descend from it, 1 citing it directly.
- This deviceK992693 Rita Model 90 Electrosurgical Accessory, Model 90Rita Medical Systems · 1999
- 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 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · 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) | K992693 | Rita Model 90 Electrosurgical Accessory, Model 90 | Rita Medical Systems | 1999 | — |
| +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 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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 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 |
|---|---|---|---|
| * | — | RITA Medical Systems Inc. - Model 70 Electrosurgical Probe Named without a submission number |
What descends from it? (77)
See all 771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021329 | Rita System | 2002 | 76 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2014 | Class II | Z-1143-2015 | Other | Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle. |
| Apr 3, 2007 | Not classified | Z-0752-2007 | Other | The product may have a cracked tray which can compromise the sterility of the product. |
| Apr 3, 2007 | Not classified | Z-0754-2007 | Other | The product may have a cracked tray which can compromise the sterility of the product. |
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 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?
The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems’ electrosurgical generator) for use in electrosurgery and is designed for the following:
Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
Incorporate thermocouples for temperature feedback.
Provide for local delivery of fluid.
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/K992693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992693: Rita Model 90 Electrosurgical Accessory, Model 90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992693
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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