510(k) Report

510(k) · Cleared

Cleared

Valleylab Force FX

K944602510(k) TraditionalCleared Jun 5, 1995259-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 5, 1995 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 319 later devices descend from it.

Decided
Jun 5, 1995
Review
259 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

319 later devices descend from it, 22 citing it directly.

Descendants, by year cleared 2017: 19 descendants cleared2011: 13 descendants cleared2003: 5 descendants cleared2010: 9 descendants cleared2005: 5 descendants cleared2019: 14 descendants cleared2002: 2 descendants cleared2013: 10 descendants cleared2021: 15 descendants cleared2006: 9 descendants cleared1999: 1 descendant cleared2025: 11 descendants cleared1998: 2 descendants cleared2001: 2 descendants cleared2014: 18 descendants cleared2023: 21 descendants cleared2007: 6 descendants cleared2008: 9 descendants cleared2020: 17 descendants cleared2018: 20 descendants cleared2012: 10 descendants cleared2009: 4 descendants cleared2022: 21 descendants cleared2016: 24 descendants cleared2004: 3 descendants cleared2015: 18 descendants cleared2024: 18 descendants cleared2026: 13 descendants cleared1995200020052010201520202025
  1. This deviceK944602 Valleylab Force FXValleylab, Inc. · 1995
  2. Descendant · cites it directly · 202 of its ownK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
  3. Descendant · cites it directly · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
  4. Descendant · 2 generations on · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
  5. Descendant · 2 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
  6. Descendant · 3 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled

Showing 5 of 319 descendants. See all descendants

Descendants cleared per year

1998: 21999: 12001: 22002: 22003: 52004: 32005: 52006: 92007: 62008: 92009: 42010: 92011: 132012: 102013: 102014: 182015: 182016: 242017: 192018: 202019: 142020: 172021: 152022: 212023: 212024: 182025: 112026: 13
1998high 24 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 319 · See all
  • K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998 · cites it directly202descendants
  • K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · cites it directly128descendants
  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · 2 generations on114descendants
  • K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · 2 generations on102descendants
  • K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · 3 generations on65descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944602Valleylab Force FXValleylab, Inc.1995—
+1K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998—
+1K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005—
+2K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20032
+2K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007—
+3K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200120
200220
200350
200430
200550
200690
200760
200890
200940
201090
2011130
2012100
2013100
2014180
2015180
2016240
2017190
2018200
2019140
2020170
2021150
2022210
2023210
2024180
2025110
2026130
FIG. 1 — Lineage of K944602, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (319)

See all 319

22 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998202
K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005128
K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries200348
K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc.199834
K050579Mega Power Electrosurgical GeneratorMegadyne Medical Products, Inc.200516
K053510IR Wireless Foot SwitchLinemaster Switch Corp.200612
K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc.20113
K052009Conmed System Model 2450 Electrosurgical GeneratorConmed Corporation20053
K143161Force FX-8(S), Force FX-8C (S), Force FX-8CA (S)Covidien20142
K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112

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?

  • Of its descendants, K981916 (Valleylab, Inc., 1998) has gone furthest, with 202 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Valleylab, Inc.

94 FDA decisions under this applicant name. See the company

  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20032 recalls
  • K010010Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure GeneratorValleylab, Inc. · 2001
  • K010013Ligasure Laparoscopic Sealer Divider Model LS1100Valleylab, Inc. · 20012 recalls
  • K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
  • K983743Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K944602 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944602: Valleylab Force FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944602

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026