510(k) · Cleared
ClearedCool-Tip RF Generator, Cool-Tip RF System Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 15, 2006 as substantially equivalent to K042216 (Valleylab, 2004) after a 110-day review. Its family tree reaches back 5 generations to 1987. 50 later devices descend from it.
- Decided
- Mar 15, 2006
- Review
- 110 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870028 (1987). 16 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 2 generations backK021329 Rita SystemRita Medical Systems · 2002
- 1 generation backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- This deviceK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- Descendant · cites it directly · 42 of its ownK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- Descendant · cites it directly · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · 2 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 2 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- Descendant · 3 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008 · cites it directly42descendants
- K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · cites it directly39descendants
- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 2 generations on38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 2 generations on29descendants
- K163105Emprint Ablation SystemCovidien, LLC · 2016 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −4 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −3 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −2 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −1 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| 0 (this device) | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| +1 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| +1 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| +2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| +2 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| +3 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K042216 | Cool-Tip RF Ablation SystemSummary page 1…edicate Devices The Cool-tip T" RF System of this submission is substantially equivalent to the Cool-tip T" RF System covered by 510(k) notification K042216 dated 11/12/04. 4. Device Description The Cool-tip-' RF System consists of a microprocessor based RF generator.… | 2004 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072687 | Valleylab Microwave Ablation Generator | 2008 | 42 |
| K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | 2010 | 39 |
| K150112 | HS Amica Devices Family | 2015 | 2 |
| K070446 | Cool-Tip Switching Controller, CTSW Control | 2007 | 2 |
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | 2016 | 0 |
| 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K072687 (Covidien Lp, Formerly Know AS Valleylab, A Divison, 2008) has gone furthest, with 42 descendants of its own.
- 5 other devices also cite its predicate K042216.
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 Cool-tipTM RF Ablation System (Generator and accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053290
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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