510(k) · Cleared

Recalled · Class II · 2018

Electrosurgical Pencil

K936304510(k) TraditionalCleared Jun 13, 1994175-day reviewClass II21 CFR 878.4400Recalls 3

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

E & M Engineering, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 13, 1994 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it. It has been recalled 3 times.

Decided: Jun 13, 1994
Review: 175 days
Class: Class II
Product code: GEI
Recalls: 3
Predicates: 0

56 later devices descend from it, 3 citing it directly.

This deviceK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994
Descendant · cites it directly · 20 of its ownK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
Descendant · cites it directly · 19 of its ownK041868 Valupen,ProfileConmed Corporation · 2004
Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
Descendant · cites it directly · 14 of its ownK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
Descendant · 2 generations on · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2004high 7 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 56 · See all

K103375Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011 · cites it directly20descendants
K041868Valupen,ProfileConmed Corporation · 2004 · cites it directly19descendants
K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007 · cites it directly14descendants
K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K936304	Electrosurgical Pencil	E & M Engineering, Inc.	1994	—
+1	K103375	Plumepen Integrated Smoke Evacuation Pencil	Medtek Devices, Inc.	2011	—
+1	K041868	Valupen,Profile	Conmed Corporation	2004	—
+2	K100597	Harmonic Focus Shears	Ethicon Endo-Surgery, LLC	2010	—
+1	K062712	Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094	Erbe USA, Inc.	2007	—
+2	K083608	Erbe Hybrid Knife	Erbe USA, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	4	0
2015	4	0
2016	4	0
2017	3	0
2018	4	0
2019	2	0
2020	7	0
2021	3	0
2022	3	0
2023	5	0
2024	1	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K936304, 1994–2026Source: 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? (56)

See all 56

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

Number	Device	Applicant	Decided	Descendants
K103375	Plumepen Integrated Smoke Evacuation Pencil	Medtek Devices, Inc.	2011	20
K041868	Valupen,Profile	Conmed Corporation	2004	19
K062712	Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094	Erbe USA, Inc.	2007	14

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 11, 2018	Class II	Z-1941-2018	Package design/selection	Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Jun 5, 2012	Class II	Z-1990-2012	Labeling mix-ups	The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode…
Jun 5, 2012	Class II	Z-1991-2012	Labeling mix-ups	The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103375 (Medtek Devices, Inc., 2011) has gone furthest, with 20 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/K936304 · printed Nov 6, 2026

Cite this page

510(k) Report. “K936304: Electrosurgical Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936304

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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