510(k) · Cleared
ClearedValleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy 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 Jun 19, 2018 as substantially equivalent to K170170 (Covidien, LLC, 2017) and 1 other predicate after a 25-day review. Its family tree reaches back 9 generations to 1991. 5 later devices descend from it.
- Decided
- Jun 19, 2018
- Review
- 25 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K911904 (1991). 32 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 5 generations between
- 3 generations backK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- 2 generations backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- 1 generation backK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- This deviceK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
- Descendant · cites it directly · 2 of its ownK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
- Descendant · cites it directly · 1 of its ownK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK250126 ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK241085 Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN…Covidien, LLC · 2024
Show all 9 generations
- Root · 9 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 8 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 7 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 6 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 5 generations backK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- 4 generations backK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- 3 generations backK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- 2 generations backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- 1 generation backK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- This deviceK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
Most influential descendants
Showing 5 of 5 · See all- K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic · 2018 · cites it directly2descendants
- K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc. · 2024 · cites it directly1descendant
- K191601Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · 2 generations on1descendant
- K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025 · 2 generations on0descendants
- K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −8 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −7 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −6 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −5 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| −4 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| −3 | K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015 | — |
| −2 | K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| −1 | K172757 | Valleylab FX8 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| 0 (this device) | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | 2018 | — |
| +1 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation… | Medtronic | 2018 | — |
| +1 | K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing… | Livsmed, Inc. | 2024 | — |
| +2 | K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019 | 1 |
| +2 | K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K170170 | Valleylab FT10 Electrosurgical PlatformSummary page 5…ate Device Trade Name: Valleylab FT10 Energy Platform Catalog Number: VLFT10GEN Common Name: Electrosurgical Generator 510(k) Number: K170170 (cleared 02/16/2017) Manufacturer: Covidien Recalls: This device has not been subject to a design-related… | 2017 |
| * | K172757 | Valleylab FX8 Electrosurgical PlatformSummary page 5…icate Device Trade Name: Valleylab FX8 Energy Platform Catalog Number: VLFX8GEN Common Name: Electrosurgical Generator 510(k) Number: K172757 (cleared 11/02/2017) Manufacturer: Covidien Recalls: This device has not been subject to a design-related… | 2017 |
What descends from it? (5)
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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K182610 (Medtronic, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K170170.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution…
Read the full statement (125 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. 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.
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181389
Report an extraction error
Are you the manufacturer?
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