510(k) · Cleared
ClearedValleylab Forcetriad Electrosurgical Generator
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 Aug 11, 2005 as substantially equivalent to K944602 (Valleylab, Inc., 1995) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1994. 128 later devices descend from it.
- Decided
- Aug 11, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932293 (1994). 7 ancestors in all. 128 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- Descendant · cites it directly · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- Descendant · 2 generations on · 56 of its ownK123444 Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · 3 generations on · 40 of its ownK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- Descendant · cites it directly · 24 of its ownK081129 Enseal…Surgrx, Inc. · 2008
- Descendant · cites it directly · 16 of its ownK171262 TempSureCynosure, Inc. · 2017
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · See all- K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · cites it directly102descendants
- K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013 · 2 generations on56descendants
- K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien · 2014 · 3 generations on40descendants
- K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc. · 2008 · cites it directly24descendants
- K171262TempSureCynosure, Inc. · 2017 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| +1 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| +2 | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +3 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| +1 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| +1 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 6 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K944602 | Valleylab Force FXSummary page 1…gical Generator is substantially equivalent in function and intended use to the following legally marketed devices: Valleylab Force FXTM Electrosurgical Generator (K944602) and the Valleylab LigaSure T M Vessel Sealing System (K981916). The ForcelriaclTM generator and the Force FXTM generator b… | 1995 |
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…ended use to the following legally marketed devices: Valleylab Force FXTM Electrosurgical Generator (K944602) and the Valleylab LigaSure T M Vessel Sealing System (K981916). The ForcelriaclTM generator and the Force FXTM generator both have monopolar and bipolar electrosurgical outputs and are int… | 1998 |
What descends from it? (128)
See all 1287 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | 2007 | 102 |
| K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | 2008 | 24 |
| K171262 | TempSure | 2017 | 16 |
| K110268 | Forcetriad Electrosurgical Generator | 2011 | 16 |
| K182365 | TempSure System | 2018 | 15 |
| K111202 | Surgical Tissue Management System | 2012 | 11 |
| K102913 | Forcetriad | 2011 | 1 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K070162 (Valleylab,A Division of Tyco Healthcare Group LP, 2007) has gone furthest, with 102 descendants of its own.
- 21 other devices also cite its predicate K944602.
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 indications for use include general (including urologic, thoracic, plastic and reconstructive, arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall…
Read the full statement (91 words)
The indications for use include general (including urologic, thoracic, plastic and reconstructive, arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of 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. Vessels (arteries, veins, fitlymph) 7mm and smaller in diameter, and bundles as large as will in the jaws of the devices can be sealed with the LigaSure vessel sealing (tissue fusion) output.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051644: Valleylab 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/K051644
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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