510(k) · Cleared
ClearedRita Starburst Sde Electrosurgical Device
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 Apr 21, 2003 after a 26-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Apr 21, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK030967 Rita Starburst Sde Electrosurgical DeviceRita Medical Systems · 2003
- Descendant · cites it directly · 8 of its ownK080451 Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK182497 OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK221074 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser…Stryker Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK233830 OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008 · cites it directly8descendants
- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · 2 generations on7descendants
- K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on5descendants
- K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022 · 3 generations on2descendants
- K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030967 | Rita Starburst Sde Electrosurgical Device | Rita Medical Systems | 2003 | — |
| +1 | K080451 | Uniblate Electrosurgical Device | AngioDynamics, Inc. | 2008 | — |
| +2 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| +2 | K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | 2022 | — |
| +3 | K233830 | OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 90/StarBurst Electrosurgical Device Named without a submission number |
What descends from it? (10)
2 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, K080451 (AngioDynamics, Inc., 2008) has gone furthest, with 8 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@ StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) 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 on 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 therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030967: Rita Starburst Sde Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030967
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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