510(k) · Cleared

Cleared

Neuroguide Analysis System

K041263510(k) TraditionalCleared Aug 3, 200484-day reviewClass II21 CFR 882.1400

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

Applied Neuroscience, Inc. · OLU Normalizing Quantitative Electroencephalograph Software

Cleared on Aug 3, 2004 as substantially equivalent to K844481 (Teca, Inc., 1985) and 14 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1980. 21 later devices descend from it.

Decided: Aug 3, 2004
Review: 84 days
Class: Class II
Product code: OLU
Recalls: None
Predicates: 15

Its longest line of descent runs back 2 generations to K801604 (1980). 15 ancestors in all. 21 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 2 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
1 generation backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
This deviceK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
Descendant · cites it directly · 9 of its ownK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
Descendant · 2 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
Descendant · cites it directly · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
Descendant · cites it directly · 4 of its ownK171414 qEEG-ProBrainmaster Technologies, Inc. · 2018
Descendant · cites it directly · 4 of its ownK050192 BRC Software ProductBrc Operations Pty Limited · 2005

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2005high 2 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 21 · See all

K092039Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009 · cites it directly9descendants
K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · cites it directly5descendants
K171414qEEG-ProBrainmaster Technologies, Inc. · 2018 · cites it directly4descendants
K050192BRC Software ProductBrc Operations Pty Limited · 2005 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K801604	Pathfinder Electrodiagnostic System	Nicolet Biomedical Instruments	1980	—
−1	K974748	Neurometric Analysis System	Nxlink, Ltd.	1998	—
0 (this device)	K041263	Neuroguide Analysis System	Applied Neuroscience, Inc.	2004	—
+1	K092039	Identevent, Version 1.0G	Optima Neuroscience, Inc.	2009	—
+2	K092573	Nihon Kohden QP-160AK Eeg Trend Program	Nihon Kohden America, Inc.	2010	—
+1	K120485	Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend…	Nihon Kohden America, Inc.	2012	—
+1	K171414	qEEG-Pro	Brainmaster Technologies, Inc.	2018	—
+1	K050192	BRC Software Product	Brc Operations Pty Limited	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	3	0
1986	2	0
1987	1	0
1989	2	0
1991	3	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0
2010	1	0
2012	2	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2020	2	0
2022	1	0
2023	2	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K041263, 1980–2026Source: 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 OLU? 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 OLU device

#1 K253015 Cognitive Function Neuroimaging (cfNI)…score 13.3 · 7 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? (18)

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
*	K844481	Neurolab II Summary page 1 …dicate/legally marketed devices upon which substantial equivalence is based: Cordis Brain State Analyzer (no FDA information available); TECA Corporation Neurolab I, IT (K844481), Brain Mapper (K890-881), Neuromapper 386 (K894889); Nicolet BEAM I, 1I (no FDA 510(k) information available); Pathfinder II (K8…	Teca, Inc.	1985	—
*	K890881	Teca 1A96, 1A97 and 1A98 Electroencephalographs	Teca, Inc.	1989	—
*	K894889	Teca Neuromapper 386 Summary page 1 …al equivalence is based: Cordis Brain State Analyzer (no FDA information available); TECA Corporation Neurolab I, IT (K844481), Brain Mapper (K890-881), Neuromapper 386 (K894889); Nicolet BEAM I, 1I (no FDA 510(k) information available); Pathfinder II (K801604); Brain Functional Map (K843598); Cadwell Labo…	Teca, Inc.	1989	—
*	K801604	Pathfinder Electrodiagnostic System Summary page 1 …; TECA Corporation Neurolab I, IT (K844481), Brain Mapper (K890-881), Neuromapper 386 (K894889); Nicolet BEAM I, 1I (no FDA 510(k) information available); Pathfinder II (K801604); Brain Functional Map (K843598); Cadwell Laboratories, Inc. 8400 (K860801) and Spectrum 32 (K860801 reference); Lexicor Medical…	Nicolet Biomedical Instruments	1980	—
*	K843598	Brain Function Mapping Option for Pathf Summary page 1 …T (K844481), Brain Mapper (K890-881), Neuromapper 386 (K894889); Nicolet BEAM I, 1I (no FDA 510(k) information available); Pathfinder II (K801604); Brain Functional Map (K843598); Cadwell Laboratories, Inc. 8400 (K860801) and Spectrum 32 (K860801 reference); Lexicor Medical Technology Neurosearch-24 (K9042…	Nicolet Biomedical Instruments	1985	—
*	K860801	Model 8400 W/Modifications (Spectrum 32) Summary page 1 …mapper 386 (K894889); Nicolet BEAM I, 1I (no FDA 510(k) information available); Pathfinder II (K801604); Brain Functional Map (K843598); Cadwell Laboratories, Inc. 8400 (K860801) and Spectrum 32 (K860801 reference); Lexicor Medical Technology Neurosearch-24 (K904269), Neurosearch-4 (K920038); Neuroscience,…	Cadwell Laboratories, Inc.	1986	—
*	K904269	Neurosearch-24 or NRS-24 Summary page 1 …r II (K801604); Brain Functional Map (K843598); Cadwell Laboratories, Inc. 8400 (K860801) and Spectrum 32 (K860801 reference); Lexicor Medical Technology Neurosearch-24 (K904269), Neurosearch-4 (K920038); Neuroscience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation. In…	Lexicor Medical Technology, Inc.	1991	—
*	K920038	Neurosearch-4 Summary page 1 …ctional Map (K843598); Cadwell Laboratories, Inc. 8400 (K860801) and Spectrum 32 (K860801 reference); Lexicor Medical Technology Neurosearch-24 (K904269), Neurosearch-4 (K920038); Neuroscience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation. Inc., Modified Brain Atlas…	Lexicor	1995	—
*	K850430	Neuroscience Map-10 Eeg Our OCR of the scanned summary read K840430, FDA’s number for Sun-Lite White Slit (Suncoast Medical Manufacturers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Neuroscience, Inc. Map-10 EEG”.	Neuroscience, Inc.	1985	—
*	K870263	Neuromapper 1620 Summary page 1 …Spectrum 32 (K860801 reference); Lexicor Medical Technology Neurosearch-24 (K904269), Neurosearch-4 (K920038); Neuroscience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation. Inc., Modified Brain Atlas 111 (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantifi…	Neuroscience, Inc.	1987	—
*	K854362	Modified Brain Atlas Iii Summary page 1 …4 (K904269), Neurosearch-4 (K920038); Neuroscience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation. Inc., Modified Brain Atlas 111 (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QSI-9500 (K904294), QS1-9200 (FDA 510(k) informat…	Bio-Logic Systems Corp.	1986	—
*	K951594	Bio-Logic Automatic Event Analysis Summary page 1 …ence, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation. Inc., Modified Brain Atlas 111 (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QSI-9500 (K904294), QS1-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhy…	Bio-Logic Systems Corp.	1995	—
*	K904294	QSI 9500 Summary page 1 …870263); Biologics Systems Corporation. Inc., Modified Brain Atlas 111 (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QSI-9500 (K904294), QS1-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhythm Software (K912938); NxLink, Inc. (K974748). (a)…	Quantified Signal Imaging, Inc.	1991	—
*	K912938	Rhythm Summary page 1 …ic Event Analysis (K951594); Quantified Signal Imaging, Inc. QSI-9500 (K904294), QS1-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhythm Software (K912938); NxLink, Inc. (K974748). (a)(4). Device Description: The NeuroGuide Analysis System (NAS) is a software program for the post-ho…	Stellate Systems	1991	—
*	K974748	Neurometric Analysis System Summary page 1 …94); Quantified Signal Imaging, Inc. QSI-9500 (K904294), QS1-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhythm Software (K912938); NxLink, Inc. (K974748). (a)(4). Device Description: The NeuroGuide Analysis System (NAS) is a software program for the post-hoc statistical analysis o…	Nxlink, Ltd.	1998	—
*	—	Cordis Brain State Analyzer Named without a submission number			—
*	—	Nicolet BEAM I, II Named without a submission number			—
*	—	QS1-9200 Named without a submission number			—

Also cleared against K844481: 1 other device →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K092039	Identevent, Version 1.0G	Optima Neuroscience, Inc.	2009	9
K120485	Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P	Nihon Kohden America, Inc.	2012	5
K171414	qEEG-Pro	Brainmaster Technologies, Inc.	2018	4
K050192	BRC Software Product	Brc Operations Pty Limited	2005	4
K112077	Hbidb - Human Brian Index Software	Corscience GmbH & Co. KG	2012	3
K121119	Bna Analysis System	Eiminda, Ltd.	2014	2
K240420	NeuroField Analysis Suite	Neurofield, Inc.	2024	0
K212684	BrainView QEEG Software	Medeia, Inc.	2023	0
K191432	cortiQ PRO	G.Tec Medical Engineering GmbH	2020	0

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?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K092039 (Optima Neuroscience, Inc., 2009) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K844481.

How does its category compare?

All OLU devices

OLU Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLU

1in 2024

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLU

Too few OLU 510(k)s in any year since 2007 to give a median.

Recalls per year · OLU

No recall names OLU since 2007.

Adverse event reports per year · OLU

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	0
2022	0	—	0
2023	2	—	0
2024	1	—	0
2025	0	—	1
2026	1	—	—

What is it indicated for?

For clinical use the NeuroGuide Analysis system is to be used by qualified medical or clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).

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/K041263 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041263: Neuroguide Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041263

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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