510(k) · Cleared

Cleared

Valleylab Force 300

K953195510(k) TraditionalCleared Aug 21, 199542-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 Aug 21, 1995 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 203 later devices descend from it.

Decided: Aug 21, 1995
Review: 42 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

203 later devices descend from it, 2 citing it directly.

This deviceK953195 Valleylab Force 300Valleylab, Inc. · 1995
Descendant · cites it directly · 202 of its ownK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
Descendant · 2 generations on · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
Descendant · 2 generations on · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
Descendant · 3 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
Descendant · 3 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled

Showing 5 of 203 descendants. See all descendants

Descendants cleared per year

1998high 18 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 203 · See all

K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998 · cites it directly202descendants
K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · 2 generations on128descendants
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 · 3 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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953195	Valleylab Force 300	Valleylab, Inc.	1995	—
+1	K981916	Ligasure Vessel Sealing System	Valleylab, Inc.	1998	—
+2	K051644	Valleylab Forcetriad Electrosurgical Generator	Valleylab	2005	—
+2	K031011	Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500	Valleylab, Inc.	2003	2
+3	K070162	Forcetriad Electrosurgical Generator; Ligasure Instruments	Valleylab,A Division of Tyco Healthcare Group LP	2007	—
+3	K092879	Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider	Valleylab	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	3	0
2004	3	0
2005	3	0
2006	6	0
2007	5	0
2008	6	0
2009	2	0
2010	4	0
2011	9	0
2012	5	0
2013	8	0
2014	10	0
2015	14	0
2016	16	0
2017	13	0
2018	18	0
2019	6	0
2020	9	0
2021	12	0
2022	10	0
2023	12	0
2024	11	0
2025	7	0
2026	10	0

FIG. 1 — Lineage of K953195, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (203)

See all 203

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

Number	Device	Applicant	Decided	Descendants
K981916	Ligasure Vessel Sealing System	Valleylab, Inc.	1998	202
K110695	Bipolar HF Device	Aesculap, Inc.	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?

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

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

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	—

https://510kreport.com/device/K953195 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953195: Valleylab Force 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953195

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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