510(k) · Cleared
ClearedRita Model 1500X Electrosurgical RF Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rita Medical Systems, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 9, 2003 after a 57-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Sep 9, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK032149 Rita Model 1500X Electrosurgical RF GeneratorRita Medical Systems, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK094009 Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK121858 The Ablation SystemHalt Medical, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- Descendant · 4 generations on · 5 of its ownK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- Descendant · 5 generations on · 4 of its ownK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K094009Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010 · cites it directly10descendants
- K121858The Ablation SystemHalt Medical, Inc. · 2012 · 2 generations on9descendants
- K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018 · 3 generations on6descendants
- K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020 · 4 generations on5descendants
- K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032149 | Rita Model 1500X Electrosurgical RF Generator | Rita Medical Systems, Inc. | 2003 | — |
| +1 | K094009 | Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI | Halt Medical, Inc. | 2010 | — |
| +2 | K121858 | The Ablation System | Halt Medical, Inc. | 2012 | — |
| +3 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| +4 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| +5 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 1500X & Model 2500 Electrosurgical RF Generator Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K094009 | Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI | 2010 | 10 |
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, K094009 (Halt Medical, Inc., 2010) has gone furthest, with 10 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 RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is 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 and the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032149: Rita Model 1500X Electrosurgical RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032149
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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