510(k) · Cleared

Recalled · 2010

Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET

K003745510(k) TraditionalCleared Jan 16, 200143-day reviewClass II21 CFR 874.1820Recalls 1

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

Rln Systems, Inc. · ETN Stimulator, Nerve

Cleared on Jan 16, 2001 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled once.

Decided: Jan 16, 2001
Review: 43 days
Class: Class II
Product code: ETN
Recalls: 1
Predicates: 0

16 later devices descend from it, 4 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.

This deviceK003745 Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ETRln Systems, Inc. · 2001
Descendant · cites it directly · 10 of its ownK050162 Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · Recalled (Class I)
Descendant · 2 generations on · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
Descendant · 3 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
Descendant · cites it directly · 4 of its ownK071349 Neurosign Laryngeal ElectrodesThe Magstim Company, Ltd. · 2007
Descendant · 4 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 3 (2023) · low 0 (2006)2026

Class I recalls in this family

K050162 Contact Emg Rotatable Endotracheal Tubecites it directly · 2005
K112686 Next Gen Emg Endotracheal Tube3 generations on · 2012

Most influential descendants

Showing 5 of 16 · See all

K050162Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · cites it directly10descendants
K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · 2 generations on8descendants
K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 3 generations on4descendants
K071349Neurosign Laryngeal ElectrodesThe Magstim Company, Ltd. · 2007 · cites it directly4descendants
K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003745	Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET	Rln Systems, Inc.	2001	—
+1	K050162	Contact Emg Rotatable Endotracheal Tube	Medtronic Xomed, Inc.	2005	Class I
+2	K094054	Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube	Nuvasive, Inc.	2010	—
+3	K110989	Neurovision Ink Printed Endotracheal Tube Electrode	Neurovision Medical Products, Inc.	2011	10
+1	K071349	Neurosign Laryngeal Electrodes	The Magstim Company, Ltd.	2007	—
+4	K221821	ATEC IOM Accessory Instruments	Alphatec Spine, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	1
2007	1	0
2009	1	0
2010	2	0
2011	1	0
2012	2	1
2013	1	0
2014	1	0
2022	1	0
2023	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K003745, 2001–2026Source: 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.

2 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 ETN device

#1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 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? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K050162	Contact Emg Rotatable Endotracheal Tube Class I	Medtronic Xomed, Inc.	2005	10
K071349	Neurosign Laryngeal Electrodes	The Magstim Company, Ltd.	2007	4
K093373	Laryngeal Surface Electrode	Spes Medica Srl	2010	1
K091874	Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656	Inomed Medizintechnik GmbH	2009	1

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2010	Not classified	Z-0798-2010	Other	This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the…

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.

K050162Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K050162 (Medtronic Xomed, Inc., 2005) has gone furthest, with 10 descendants of its own.

How does its category compare?

All ETN devices

ETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETN

1in 2025

2007high 9 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ETN

98in 2023

2007high 179 (2012) · low 98 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ETN

1in 2023

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ETN

1,145in 2025

2007high 1,145 (2025) · low 5 (2007)2025

MAUDE reports naming product code ETN, 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	2	—	0	5
2008	2	—	1	5
2009	5	115	0	22
2010	3	168	1	26
2011	9	115	0	55
2012	7	179	0	187
2013	1	—	0	270
2014	2	—	0	137
2015	1	—	0	202
2016	2	—	1	145
2017	0	—	0	117
2018	0	—	0	250
2019	0	—	2	314
2020	1	—	1	238
2021	1	—	1	197
2022	2	—	0	247
2023	5	98	1	390
2024	2	—	0	748
2025	1	—	0	1,145
2026	2	—	0	—

https://510kreport.com/device/K003745 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003745: Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003745

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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