510(k) · Cleared

Recalled · Class II · 2018

Mega Power Electrosurgical Generator

K050579510(k) TraditionalCleared Mar 24, 200517-day reviewClass II21 CFR 878.4400Recalls 1

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

Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 24, 2005 as substantially equivalent to K944602 (Valleylab, Inc., 1995) after a 17-day review. Its family tree reaches back 1 generation to 1995. 16 later devices descend from it. It has been recalled once.

Decided: Mar 24, 2005
Review: 17 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K944602 (1995). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK944602 Valleylab Force FXValleylab, Inc. · 1995
This deviceK050579 Mega Power Electrosurgical GeneratorMegadyne Medical Products, Inc. · 2005
Descendant · cites it directly · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
Descendant · 2 generations on · 9 of its ownK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
Descendant · 2 generations on · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
Descendant · 3 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
Descendant · cites it directly · 2 of its ownK193145 Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc. · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 16 · See all

K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · cites it directly12descendants
K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec · 2009 · 2 generations on9descendants
K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · 2 generations on8descendants
K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 3 generations on3descendants
K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc. · 2020 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944602	Valleylab Force FX	Valleylab, Inc.	1995	—
0 (this device)	K050579	Mega Power Electrosurgical Generator	Megadyne Medical Products, Inc.	2005	—
+1	K053510	IR Wireless Foot Switch	Linemaster Switch Corp.	2006	2
+2	K083161	Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)	Conmed Linvatec	2009	—
+2	K100638	Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch…	Depuy Mitek, A Johnson & Johnson Company	2010	—
+3	K152777	Bovie Disposable Bipolar Ablator	Bovie Medical Corporation	2016	2
+1	K193145	Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch	Megadyne Medical Products, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2009	1	0
2010	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2018	1	0
2019	1	0
2020	1	0
2022	1	0
2023	1	0
2025	2	0

FIG. 1 — Lineage of K050579, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K944602	Valleylab Force FX Summary page 2 …21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories E. PredicateDevice Valleylab Force FXc (K944602). F. Applicant Device Description The Megadyne MEGA Power Electrosurgical Generator is a microprocessor control…	Valleylab, Inc.	1995	—

Also cleared against K944602: 21 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K053510	IR Wireless Foot Switch	Linemaster Switch Corp.	2006	12
K193145	Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch	Megadyne Medical Products, Inc.	2020	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 15, 2018	Class II	Z-2792-2018	Use error	If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K053510 (Linemaster Switch Corp., 2006) has gone furthest, with 12 descendants of its own.
21 other devices also cite its predicate K944602.

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	—

What is it indicated for?

General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050579: Mega Power 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/K050579

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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