510(k) · Cleared
ClearedForcetriad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco H · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 6, 2011 as substantially equivalent to K051644 (Valleylab, 2005) after a 217-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- May 6, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932293 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- This deviceK102913 ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H · 2011
- Descendant · cites it directly · 0 of its ownK110695 Bipolar HF DeviceAesculap, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110695Bipolar HF DeviceAesculap, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| 0 (this device) | K102913 | Forcetriad | Covidien, Formerly Valleylab, A Division of Tyco H | 2011 | — |
| +1 | K110695 | Bipolar HF Device | Aesculap, Inc. | 2011 | — |
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 |
|---|---|---|
| 2011 | 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.
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 |
|---|---|---|---|
| K110695 | Bipolar HF Device | 2011 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K110695 (Aesculap, Inc., 2011) has gone furthest, with 0 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 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 (96 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, adhesilysis, oophorectomy, etc. Vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) 7mm and smaller in diameter, and bundles as large as will fit 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/K102913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102913: Forcetriad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102913
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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