510(k) · Cleared
Recalled · Class II · 2023Valleylab FT10 Electrosurgical Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 12, 2019 as substantially equivalent to K182610 (Medtronic, 2018) after a 25-day review. Its family tree reaches back 12 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 12, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K942299 (1995). 90 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations between
- 3 generations backK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- 2 generations backK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
- 1 generation backK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
- This deviceK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019
- Descendant · cites it directly · 0 of its ownK241085 Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN…Covidien, LLC · 2024
Show all 12 generations
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 10 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 9 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 8 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 7 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 6 generations backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- 5 generations backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- 4 generations backK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- 3 generations backK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- 2 generations backK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
- 1 generation backK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
- This deviceK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019
Most influential descendants
Showing 1 of 1 · See all- K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −11 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −10 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −9 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −8 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −7 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −6 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| −5 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| −4 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| −3 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| −2 | K093203 | Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831… | Medtronic, Inc. | 2010 | — |
| −1 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation… | Medtronic | 2018 | — |
| 0 (this device) | K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019 | — |
| +1 | K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN… | Covidien, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Summary page 4…ate Device Trade Name: Valleylab FT10 Energy Platform Catalog Number: VLFT10GEN Common Name: Electrosurgical Generator 510(k) Number: K182610 (cleared 12/19/2018) Manufacturer: Covidien Recalls: This device has not been subject to a design-related… | 2018 |
| † | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2023 | Class II | Z-0631-2024 | Software Manufacturing/Software Deployment | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 90 ancestors have a recall of any class.
- Of its descendants, K241085 (Covidien, LLC, 2024) has gone furthest, with 0 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. 2019, 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 Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible…
Read the full statement (112 words)
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191601: Valleylab FT10 Electrosurgical Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191601
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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