510(k) · Cleared
ClearedValleylab FX8 Electrosurgical Platform
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 Nov 2, 2017 as substantially equivalent to K151649 (Covidien, 2015) and 1 other predicate after a 50-day review. Its family tree reaches back 8 generations to 1991. 6 later devices descend from it.
- Decided
- Nov 2, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911904 (1991). 31 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 7 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 6 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 5 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 4 generations backK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- 3 generations backK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- 2 generations backK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- 1 generation backK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- This deviceK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- Descendant · cites it directly · 5 of its ownK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
- Descendant · 2 generations on · 2 of its ownK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
- Descendant · 2 generations on · 1 of its ownK241138 ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel…Livsmed, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK250126 ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien · 2018 · cites it directly5descendants
- K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic · 2018 · 2 generations on2descendants
- K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc. · 2024 · 2 generations on1descendant
- K191601Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · 3 generations on1descendant
- K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −7 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −6 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −5 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −4 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| −3 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| −2 | K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015 | — |
| −1 | K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| 0 (this device) | K172757 | Valleylab FX8 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| +1 | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | 2018 | — |
| +2 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation… | Medtronic | 2018 | — |
| +2 | K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing… | Livsmed, Inc. | 2024 | — |
| +3 | K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019 | 1 |
| +3 | K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025 | — |
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 | 2 | 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 |
|---|---|---|---|
| * | K151649 | Valleylab FT10 Electrosurgical PlatformSummary page 4…) Submitter / Holder: Covidien 5920 Longbow Drive Boulder, CO, 80301 Predicate 510(k) #: K151649, K170170 Identification of Reference Predicate Trade/Proprietary Name: Force FX Generators Common/Usual Name:… | 2015 |
| * | K170170 | Valleylab FT10 Electrosurgical PlatformSummary page 4…er / Holder: Covidien 5920 Longbow Drive Boulder, CO, 80301 Predicate 510(k) #: K151649, K170170 Identification of Reference Predicate Trade/Proprietary Name: Force FX Generators Common/Usual Name: El… | 2017 |
| † | K944602 | Valleylab Force FX | 1995 |
| † | K143161 | Force FX-8(S), Force FX-8C (S), Force FX-8CA (S) | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | 2018 | 5 |
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 26 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K181389 (Covidien, 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K151649.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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/K172757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172757: Valleylab FX8 Electrosurgical Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172757
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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