510(k) · Cleared

Recalled · Class I · 2024

Mega 2000 Soft Dual Cord Patient Return Electrode Pad

K031285510(k) TraditionalCleared May 19, 200326-day reviewClass II21 CFR 878.4400Recalls 2 (2 Class I)

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 May 19, 2003 as substantially equivalent to K021077 (Megadyne Medical Products, Inc., 2002) after a 26-day review. Its family tree reaches back 4 generations to 1982. 6 of the 11 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.

Decided: May 19, 2003
Review: 26 days
Class: Class II
Product code: GEI
Recalls: 2 (2 Class I)
Predicates: 1

Its longest line of descent runs back 4 generations to K822572 (1982). 5 ancestors in all, the oldest K801694 (1980). 5 later devices descend from it, 1 citing it directly. 6 of the 11 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK822572 Polyhesive Patient Return ElectrodeValleylab, Inc. · 1982
3 generations backK972273 TBDMegadyne Medical Products, Inc. · 1997
2 generations backK982826 MEGA 2000Megadyne Medical Products, Inc. · 1998 · Recalled (Class I)
1 generation backK021077 Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Recalled (Class I)
This deviceK031285 Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003
Descendant · cites it directly · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
Descendant · 2 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK233644 Megadyne Patient Return Electrode Pad - Universal Dual (model 0846)…Megadyne Medical Products, Inc. · 2024 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK210727 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2022 · Recalled
Descendant · 3 generations on · 0 of its ownK183148 OKLand Patient Return Electrode PadAuckland Medical Polymer (Tianjin) Co., Ltd. · 2020

Class I recalls in this family

K021077 Mega 2000 Soft Patient Return Electrode Paddirect predicate · 2002
K982826 MEGA 20002 generations back · 1998
K080741 Mega Soft Reusable Patient Return Electrodecites it directly · 2008
K133726 Mega Soft Universal Patient Return Electrode2 generations on · 2014

Most influential descendants

Showing 5 of 5 · See all

K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · cites it directly4descendants
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on3descendants
K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient…Megadyne Medical Products, Inc. · 2024 · 3 generations on0descendants
K210727HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2022 · 3 generations on0descendants
K183148OKLand Patient Return Electrode PadAuckland Medical Polymer (Tianjin) Co., Ltd. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K822572	Polyhesive Patient Return Electrode	Valleylab, Inc.	1982	—
−3	K972273	TBD	Megadyne Medical Products, Inc.	1997	—
−2	K982826	MEGA 2000	Megadyne Medical Products, Inc.	1998	Class I
−1	K021077	Mega 2000 Soft Patient Return Electrode Pad	Megadyne Medical Products, Inc.	2002	Class I
0 (this device)	K031285	Mega 2000 Soft Dual Cord Patient Return Electrode Pad	Megadyne Medical Products, Inc.	2003	—
+1	K080741	Mega Soft Reusable Patient Return Electrode	Megadyne Medical Products, Inc.	2008	Class I
+2	K133726	Mega Soft Universal Patient Return Electrode	Megadyne Medical Products, Inc.	2014	Class I
+3	K233644	Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne…	Megadyne Medical Products, Inc.	2024	Class I
+3	K210727	HotDog Warming Mattress + Return Electrode	Augustine Temperature Management, LLC	2022	2
+3	K183148	OKLand Patient Return Electrode Pad	Auckland Medical Polymer (Tianjin) Co., Ltd.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	1
2014	1	1
2020	1	0
2022	1	0
2024	1	1

FIG. 1 — Lineage of K031285, 1982–2024Source: 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.

6 devices in this family have a Class I recall. 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
*	K021077	Mega 2000 Soft Patient Return Electrode Pad	Megadyne Medical Products, Inc.	2002	Class I

Also cleared against K021077: 1 other device →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080741	Mega Soft Reusable Patient Return Electrode Class I	Megadyne Medical Products, Inc.	2008	4

Has anything in its family been recalled? (6 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 17, 2024	Class I	Z-2250-2024	Unknown/Undetermined by firm	To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Jun 1, 2023	Class I	Z-1996-2023	Under Investigation by firm	Firm has received reports of patient burns in surgical procedures where device was used.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K982826MEGA 2000Megadyne Medical Products, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
2 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K080741 (Megadyne Medical Products, Inc., 2008) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K021077.

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?

The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031285 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031285: Mega 2000 Soft Dual Cord Patient Return Electrode Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031285

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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