510(k) Report

510(k) · Cleared

Cleared

FORCE 2

K921884510(k) TraditionalCleared Dec 15, 1992238-day reviewClass II21 CFR 884.4120

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

Valleylab, Inc. · HGI Electrocautery, Gynecologic (And Accessories)

Cleared on Dec 15, 1992 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,365 later devices descend from it.

Decided
Dec 15, 1992
Review
238 days
Class
Class II
Product code
HGI
Recalls
None
Predicates
0

1,365 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 10 descendants cleared1998: 2 descendants cleared2004: 16 descendants cleared2008: 49 descendants cleared2003: 22 descendants cleared2007: 22 descendants cleared2005: 21 descendants cleared2006: 27 descendants cleared1999: 1 descendant cleared2001: 4 descendants cleared2016: 71 descendants cleared2015: 56 descendants cleared2013: 50 descendants cleared2010: 42 descendants cleared2019: 55 descendants cleared2025: 136 descendants cleared2011: 29 descendants cleared2012: 40 descendants cleared2009: 34 descendants cleared2018: 63 descendants cleared2000: 2 descendants cleared2022: 87 descendants cleared2014: 50 descendants cleared2020: 64 descendants cleared2021: 70 descendants cleared2017: 69 descendants cleared2023: 81 descendants cleared2024: 106 descendants cleared2026: 86 descendants cleared1990200020102020
  1. This deviceK921884 FORCE 2Valleylab, Inc. · 1992
  2. Descendant · cites it directly · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  3. Descendant · 2 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  4. Descendant · 3 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  5. Descendant · 4 generations on · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  6. Descendant · 4 generations on · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002

Showing 5 of 1,365 descendants. See all descendants

Descendants cleared per year

1998: 21999: 12000: 22001: 42002: 102003: 222004: 162005: 212006: 272007: 222008: 492009: 342010: 422011: 292012: 402013: 502014: 502015: 562016: 712017: 692018: 632019: 552020: 642021: 702022: 872023: 812024: 1062025: 1362026: 86
1998high 136 (2025) · low 1 (1999)2026

Most influential descendants

Showing 5 of 1,365 · See all
  • K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · cites it directly1,219descendants
  • K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 2 generations on1,073descendants
  • K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 3 generations on1,069descendants
  • K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · 4 generations on800descendants
  • K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · 4 generations on799descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921884FORCE 2Valleylab, Inc.1992—
+1K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
+3K000944Thermage Thermacool SystemThermage, Inc.2000—
+4K013034Modification to: Thermacool IiaThermage, Inc.2001—
+4K013639Thermage Thermacool TC SystemThermage, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200020
200140
2002100
2003220
2004160
2005210
2006270
2007220
2008490
2009340
2010420
2011290
2012400
2013500
2014500
2015560
2016710
2017690
2018630
2019550
2020640
2021700
2022870
2023810
20241060
20251360
2026860
FIG. 1 — Lineage of K921884, 1992–2026Source: 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 HGI? 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 HGI device

  1. #1 K202915 IRIS Thermocoagulator and Digital Colposcopescore 2.1 · 4 generations · no Class I recall
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? (1,365)

See all 1,365

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

NumberDeviceApplicantDecidedDescendants
K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219
K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular2002102
K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242

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, K973478 (Arthrocare Corp., 1998) has gone furthest, with 1,219 descendants of its own.

How does its category compare?

All HGI devices

HGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGI

1in 2021

2007: 12012: 12014: 12016: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGI

Too few HGI 510(k)s in any year since 2007 to give a median.

Recalls per year · HGI

7in 2021

2012: 12014: 12019: 32021: 7
2007high 7 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGI

41in 2025

2008: 12009: 12010: 12011: 22013: 62014: 12015: 272016: 562017: 332018: 302019: 1272020: 1022021: 1002022: 1042023: 612024: 442025: 41
2007high 127 (2019) · low 0 (2007)2025

MAUDE reports naming product code HGI, 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
20071—00
20080—01
20090—01
20100—01
20110—02
20121—10
20130—06
20141—11
20150—027
20161—056
20170—033
20180—030
20190—3127
20200—0102
20211—7100
20220—0104
20230—061
20240—044
20250—041
20260—0—

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 HGI

The HGI category page

  • K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021
  • K152843Liger Medical HTU-110Liger Medical, LLC · 2016
  • K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
  • K121881Domain Surgical SystemDomain Surgical, Inc. · 2012
  • K070877Endocervical Electrode # 2Modern Medical Equipment Mfg., Ltd. · 2007

https://510kreport.com/device/K921884 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921884: FORCE 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921884

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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