510(k) · Cleared

Cleared

Neurosign 400, 4 Channel Motor Nerve Monitor

K991583510(k) SpecialCleared May 19, 199912-day reviewClass II21 CFR 874.1820

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

The Magstim Company, Ltd. · ETN Stimulator, Nerve

Cleared on May 19, 1999 as substantially equivalent to K964869 (The Magstim Company, Ltd., 1997) and 1 other predicate after a 12-day review. Its family tree reaches back 1 generation to 1992. 44 later devices descend from it.

Decided: May 19, 1999
Review: 12 days
Class: Class II
Product code: ETN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923056 (1992). 2 ancestors in all. 44 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
This deviceK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
Descendant · cites it directly · 38 of its ownK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
Descendant · 2 generations on · 32 of its ownK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
Descendant · 3 generations on · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
Descendant · 3 generations on · 19 of its ownK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
Descendant · 2 generations on · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2005high 5 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 44 · See all

K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeTechnomed Europe · 2005 · cites it directly38descendants
K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007 · 2 generations on32descendants
K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · 3 generations on19descendants
K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007 · 3 generations on19descendants
K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · 2 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923056	Neurosign Model 100	The Magstim Company, Ltd.	1992	1
0 (this device)	K991583	Neurosign 400, 4 Channel Motor Nerve Monitor	The Magstim Company, Ltd.	1999	—
+1	K050325	Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar…	Technomed Europe	2005	—
+2	K062996	Disposable Monopolar and Bipolar Stimulator Probes	Axon Systems, Inc.	2007	—
+3	K090838	Stimulus/Dissection Instruments	Axon Systems, Inc.	2009	—
+3	K063729	Disposable Pedicle Screw Probe, Model 3603-00	Technomed Europe	2007	—
+2	K103128	Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip…	Cadwell Lab, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2008	1	0
2009	2	0
2010	2	0
2011	5	0
2012	3	0
2013	1	0
2014	5	0
2015	1	0
2016	4	0
2018	2	0
2019	2	0
2022	2	0
2023	5	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K991583, 1992–2026Source: 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.

Planning a device in ETN? 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? (2)

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
*	K964869	Neurosign 800, 8 Channel Motor Nerve Monitor Summary page 1 …. The Neurosign 400 is similar to the following products which are currently in commercial distribution in the U.S.A. Neurosign 800 Nerve Monitor, The Magstim Company, K964869 Neurosign 100 Nerve Monitor, The Magstim Company, K923056/A The safety and effectiveness of the Neurosign 400 has been establish…	The Magstim Company, Ltd.	1997	—
*	K923056	Neurosign Model 100 Summary page 1 …which are currently in commercial distribution in the U.S.A. Neurosign 800 Nerve Monitor, The Magstim Company, K964869 Neurosign 100 Nerve Monitor, The Magstim Company, K923056/A The safety and effectiveness of the Neurosign 400 has been established through various techniques. The history of the similar…	The Magstim Company, Ltd.	1992	1

Also cleared against K964869: 2 other devices →

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K050325	Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe	Technomed Europe	2005	38
K083242	Neurosign Avalanche Motor Nerve Monitor	The Magstim Company, Ltd.	2009	4
K111647	C2 Nervemonitor System with Accessories	Inomed Medizintechnik GmbH	2011	2

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K050325 (Technomed Europe, 2005) has gone furthest, with 38 descendants of its own.
2 other devices also cite its predicate K964869.

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	—

What is it indicated for?

To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

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/K991583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991583: Neurosign 400, 4 Channel Motor Nerve Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991583

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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