510(k) · Cleared
ClearedForcetriad Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Know AS Valleylab, A Divison · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 31, 2011 as substantially equivalent to K051644 (Valleylab, 2005) and 4 other predicates after a 123-day review. Its family tree reaches back 5 generations to 1991. 16 later devices descend from it.
- Decided
- May 31, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K911904 (1991). 28 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 4 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 3 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 2 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 1 generation backK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- This deviceK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · cites it directly · 10 of its ownK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
- Descendant · 2 generations on · 8 of its ownK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
- Descendant · 3 generations on · 5 of its ownK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018
- Descendant · cites it directly · 3 of its ownK223039 da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151649Valleylab FT10 Electrosurgical PlatformCovidien · 2015 · cites it directly10descendants
- K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017 · 2 generations on8descendants
- K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017 · 2 generations on6descendants
- K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien · 2018 · 3 generations on5descendants
- K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −4 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −3 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −2 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −1 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| 0 (this device) | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +1 | K151649 | Valleylab FT10 Electrosurgical Platform | Covidien | 2015 | — |
| +2 | K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| +2 | K172757 | Valleylab FX8 Electrosurgical Platform | Covidien, LLC | 2017 | — |
| +3 | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | 2018 | — |
| +1 | K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2022 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K051644 | Valleylab Forcetriad Electrosurgical GeneratorSummary page 1…Predicate Devices This version of the ForceTriad TM Electrosurgical Generator is substantially equivalent to the ForceTriad TM Electrosurgical Generators cleared under K051 644 and K070162. The purpose of this submission is to notify FDA of the software updates to the ForceTriadm Electrosurgical Generator… | 2005 |
| * | K070162 | Forcetriad Electrosurgical Generator; Ligasure InstrumentsSummary page 1…evices This version of the ForceTriad TM Electrosurgical Generator is substantially equivalent to the ForceTriad TM Electrosurgical Generators cleared under K051 644 and K070162. The purpose of this submission is to notify FDA of the software updates to the ForceTriadm Electrosurgical Generator that activa… | 2007 |
| * | K060484 | Erbe Vio Esu, Model Vio 300 DSummary page 1…osurgical Generator that activates a bipolar resection feature. This mode is substantially equivalent to the resectoscope use feature on the ERBE TM VIO 300 0 generator (K060484, including accessories), the Karl Storz Endocopy Autocon 11400 Electrosurgical Generator (K062464), and the Gyrus ACMI PlasmaKine… | 2006 |
| * | K062464 | Modification to Autocon II 400 Electrosurgical GeneratorSummary page 1…ent to the resectoscope use feature on the ERBE TM VIO 300 0 generator (K060484, including accessories), the Karl Storz Endocopy Autocon 11400 Electrosurgical Generator (K062464), and the Gyrus ACMI PlasmaKineti CTM SuperPulse Generator (K100816). This feature is compatible with the Karl Storz (KSEA) Bipol… | 2007 |
| * | K100816 | PK Superpulse Sysem Generator Model 744000Summary page 1…or (K060484, including accessories), the Karl Storz Endocopy Autocon 11400 Electrosurgical Generator (K062464), and the Gyrus ACMI PlasmaKineti CTM SuperPulse Generator (K100816). This feature is compatible with the Karl Storz (KSEA) Bipolar Electrotome resectoscope (K061541) and the newly designed adaptor… | 2010 |
| † | K061541 | Ksea Bipolar Electrotome | 2006 |
| † | K073450 | Sutter Electrosurgical Cables | 2008 |
| † | K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | 2007 |
What descends from it? (16)
See all 163 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 20 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K151649 (Covidien, 2015) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K051644.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing,). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph…
Read the full statement (243 words)
The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing,). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endloscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCI solution (saline) as the irrigation medium.
The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSdre 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/K110268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110268: Forcetriad Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110268
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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