510(k) · Cleared
ClearedCool-tip RF Ablation System E Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 25, 2022 as substantially equivalent to K052796 (Valleylab, 2006) and 1 other predicate after a 491-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- Feb 25, 2022
- Review
- 491 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K870028 (1987). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 5 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 4 generations backK021329 Rita SystemRita Medical Systems · 2002
- 3 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 2 generations backK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 1 generation backK070446 Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP · 2007
- This deviceK203150 Cool-tip RF Ablation System E SeriesCovidien, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −6 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −5 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −4 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −3 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −2 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −1 | K070446 | Cool-Tip Switching Controller, CTSW Control | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| 0 (this device) | K203150 | Cool-tip RF Ablation System E Series | Covidien, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K052796 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesSummary page 4…Name Classification Name and Class 510(k) Number(s) Cool-tip™ RF Ablation K052796 Electrosurgical, Cutting & Coagulation & Accessories Generator… | 2006 |
| * | K070446 | Cool-Tip Switching Controller, CTSW ControlSummary page 4…(Primary Predicate Device) Cool-tip™ Switching Electrosurgical, Cutting & Coagulation & Accessories K070446 Controller 6 Intended Use / Indications for Use The Covidien Cool-tipTM RF Ablation System E Series (generator, pump, pati… | 2007 |
| † | K133821 | Emprint Ablation System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 5 other devices also cite its predicate K052796.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 Cool-tip RF Ablation System E Series (generator, pump, patient return electrodes, water container, active electrodes, footswitch, and accessories) is intended for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, including partial or complete ablation of non-resectable liver tumors.
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/K203150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203150: Cool-tip RF Ablation System E Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203150
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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