510(k) · Cleared

Cleared

Premie T.D.S. Electrosurgical Grounding Pad

K855084510(k) TraditionalCleared May 6, 1986138-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

Conmedcorp · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 6, 1986 after a 138-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.

Decided: May 6, 1986
Review: 138 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

12 later devices descend from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.

This deviceK855084 Premie T.D.S. Electrosurgical Grounding PadConmedcorp · 1986
Descendant · cites it directly · 11 of its ownK994428 E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
Descendant · 2 generations on · 4 of its ownK140500 SkintactLeonhard Lang GmbH · 2014
Descendant · 2 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
Descendant · 3 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2000high 3 (2024) · low 0 (2001)2026

Class I recalls in this family

K080741 Mega Soft Reusable Patient Return Electrode2 generations on · 2008
K133726 Mega Soft Universal Patient Return Electrode3 generations on · 2014
K233644 Megadyne Patient Return Electrode Pad -…4 generations on · 2024

Most influential descendants

Showing 5 of 12 · See all

K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000 · cites it directly11descendants
K140500SkintactLeonhard Lang GmbH · 2014 · 2 generations on4descendants
K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 2 generations on4descendants
K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · 3 generations on3descendants
K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K855084	Premie T.D.S. Electrosurgical Grounding Pad	Conmedcorp	1986	—
+1	K994428	E7512 Premie Rem Polyhesive II Patient Return Electrode	Valleylab, Inc.	2000	—
+2	K140500	Skintact	Leonhard Lang GmbH	2014	—
+2	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	—
+3	K133726	Mega Soft Universal Patient Return Electrode	Megadyne Medical Products, Inc.	2014	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2008	1	1
2014	2	1
2016	1	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2024	3	1

FIG. 1 — Lineage of K855084, 1986–2024Source: 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.

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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K994428	E7512 Premie Rem Polyhesive II Patient Return Electrode	Valleylab, Inc.	2000	11

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

What does this lineage say?

Of its descendants, K994428 (Valleylab, Inc., 2000) has gone furthest, with 11 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/K855084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K855084: Premie T.D.S. Electrosurgical Grounding Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K855084

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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