510(k) · Cleared
ClearedRita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode
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 Dec 2, 1999 after a 13-day review. The FDA summary names its predicate without a number. 183 later devices descend from it.
- Decided
- Dec 2, 1999
- Review
- 13 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
183 later devices descend from it, 6 citing it directly.
- This deviceK993944 Rita Model 1500 Electrosurgical Generator, Power…Rita Medical Systems · 1999
- Descendant · cites it directly · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- Descendant · 2 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- Descendant · cites it directly · 76 of its ownK021329 Rita SystemRita Medical Systems · 2002
- Descendant · cites it directly · 75 of its ownK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- Descendant · 2 generations on · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
Showing 5 of 183 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 183 · See all- K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · cites it directly92descendants
- K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 2 generations on90descendants
- K021329Rita SystemRita Medical Systems · 2002 · cites it directly76descendants
- K042216Cool-Tip RF Ablation SystemValleylab · 2004 · cites it directly75descendants
- K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 2 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993944 | Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable… | Rita Medical Systems | 1999 | — |
| +1 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| +2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| +1 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| +1 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| +2 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 13 | 0 |
| 2007 | 5 | 0 |
| 2008 | 13 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 11 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 13 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 21 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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 Model 500 Electrosurgical RF Generator Named without a submission number |
What descends from it? (183)
See all 1836 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011722 | Atricure Bipolar Coagulation System | 2001 | 92 |
| K021329 | Rita System | 2002 | 76 |
| K042216 | Cool-Tip RF Ablation System | 2004 | 75 |
| K094009 | Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI | 2010 | 10 |
| K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System | 2006 | 2 |
| K120116 | Serf Ablation System Serf Ablation Needle | 2012 | 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, K011722 (AtriCure, Inc., 2001) has gone furthest, with 92 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 1500 RF Electrosurgical Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
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/K993944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993944
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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