510(k) · Cleared

Cleared

Disposable Patient Return Electrode

K972269510(k) TraditionalCleared Jul 9, 199722-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 9, 1997 after a 22-day review. The FDA summary names no predicate by number. 3 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.

Decided: Jul 9, 1997
Review: 22 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

21 later devices descend from it, 2 citing it directly. 3 of the 22 devices in this family, counting this one, have a Class I recall.

This deviceK972269 Disposable Patient Return ElectrodeErbe USA, Inc. · 1997
Descendant · cites it directly · 19 of its ownK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
Descendant · 2 generations on · 14 of its ownK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
Descendant · 2 generations on · 4 of its ownK140500 SkintactLeonhard Lang GmbH · 2014
Descendant · 3 generations on · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
Descendant · 3 generations on · 3 of its ownK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 3 (2024) · low 0 (2004)2026

Class I recalls in this family

K080741 Mega Soft Reusable Patient Return Electrode3 generations on · 2008
K133726 Mega Soft Universal Patient Return Electrode4 generations on · 2014
K233644 Megadyne Patient Return Electrode Pad -…5 generations on · 2024

Most influential descendants

Showing 5 of 21 · See all

K030362Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003 · cites it directly19descendants
K063161Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006 · 2 generations on14descendants
K140500SkintactLeonhard Lang GmbH · 2014 · 2 generations on4descendants
K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on4descendants
K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972269	Disposable Patient Return Electrode	Erbe USA, Inc.	1997	—
+1	K030362	Skintact Cool Contact Electrosurgical Grounding Plates	Leonhard Lang GmbH	2003	—
+2	K063161	Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel	Leonhard Lang GmbH	2006	—
+2	K140500	Skintact	Leonhard Lang GmbH	2014	—
+3	K080741	Mega Soft Reusable Patient Return Electrode	Megadyne Medical Products, Inc.	2008	Class I
+3	K173877	BOWA Neutral Electrodes	Bowa-Electronics GmbH & Co. KG	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	1	0
2007	1	0
2008	1	1
2009	1	0
2010	1	0
2013	1	0
2014	2	1
2016	2	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	2	0
2024	3	1

FIG. 1 — Lineage of K972269, 1997–2024Source: 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.

3 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K030362	Skintact Cool Contact Electrosurgical Grounding Plates	Leonhard Lang GmbH	2003	19
K023812	Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and P/N: 20193-085	Erbe USA, Inc.	2002	0

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

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.

K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 4 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 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K030362 (Leonhard Lang GmbH, 2003) has gone furthest, with 19 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	—

What is it indicated for?

ERBE Disposable Patient Return Electrodes are Indicated for Use only in conjunction with Electrosurgical Generators for cutting and coagulation of human tissue.

The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface).

The Electrodes must be applied as close as possible to the operative site, preferably on the thigh or upper arm of the patient, and must not be applied to scars, infected skin, bony protrusions, or over metal implants.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972269 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972269: Disposable Patient Return Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972269

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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