510(k) · Cleared

Cleared

Neurosign 800, 8 Channel Motor Nerve Monitor

K964869510(k) TraditionalCleared May 14, 1997161-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 14, 1997 after a 161-day review. The FDA summary names no predicate by number. 45 later devices descend from it.

Decided: May 14, 1997
Review: 161 days
Class: Class II
Product code: ETN
Recalls: None
Predicates: 0

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

This deviceK964869 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1997
Descendant · cites it directly · 44 of its ownK991583 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

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

1999high 5 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 45 · See all

K991583Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999 · cites it directly44descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964869	Neurosign 800, 8 Channel Motor Nerve Monitor	The Magstim Company, Ltd.	1997	—
+1	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
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 K964869, 1997–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K991583	Neurosign 400, 4 Channel Motor Nerve Monitor	The Magstim Company, Ltd.	1999	44
K050325	Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe	Technomed Europe	2005	38
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?

Of its descendants, K991583 (The Magstim Company, Ltd., 1999) has gone furthest, with 44 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	—

What is it indicated for?

The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

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/K964869 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964869: Neurosign 800, 8 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/K964869

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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