510(k) · Cleared

Cleared

Neurometric Analysis System

K974748510(k) TraditionalCleared Jul 10, 1998203-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

Nxlink, Ltd. · OLU Normalizing Quantitative Electroencephalograph Software

Cleared on Jul 10, 1998 as substantially equivalent to K844481 (Teca, Inc., 1985) and 12 other predicates after a 203-day review. Its family tree reaches back 1 generation to 1980. 29 later devices descend from it.

Decided: Jul 10, 1998
Review: 203 days
Class: Class II
Product code: OLU
Recalls: None
Predicates: 14

Its longest line of descent runs back 1 generation to K801604 (1980). 13 ancestors in all. 29 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
This deviceK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
Descendant · cites it directly · 21 of its ownK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
Descendant · 2 generations on · 9 of its ownK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
Descendant · 3 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
Descendant · cites it directly · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016
Descendant · 2 generations on · 5 of its ownK181179 BrainScope OneBrainscope Company, Inc. · 2018

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2004high 3 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 29 · See all

K041263Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004 · cites it directly21descendants
K092039Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009 · 2 generations on9descendants
K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 3 generations on7descendants
K161068Ahead 300Brainscope Company, Inc. · 2016 · cites it directly6descendants
K181179BrainScope OneBrainscope Company, Inc. · 2018 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801604	Pathfinder Electrodiagnostic System	Nicolet Biomedical Instruments	1980	—
0 (this device)	K974748	Neurometric Analysis System	Nxlink, Ltd.	1998	—
+1	K041263	Neuroguide Analysis System	Applied Neuroscience, Inc.	2004	—
+2	K092039	Identevent, Version 1.0G	Optima Neuroscience, Inc.	2009	—
+3	K092573	Nihon Kohden QP-160AK Eeg Trend Program	Nihon Kohden America, Inc.	2010	—
+1	K161068	Ahead 300	Brainscope Company, Inc.	2016	—
+2	K181179	BrainScope One	Brainscope Company, Inc.	2018	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2009	1	0
2010	1	0
2012	2	0
2013	1	0
2014	1	0
2015	1	0
2016	2	0
2017	1	0
2018	3	0
2019	2	0
2020	2	0
2022	1	0
2023	3	0
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K974748, 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? (17)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

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, II (K844481), Brain Mapper (K850-881), Neuromapper 386 (K894889); Nicolet BEAM L 1I (no FDA 510(k) information available); Pathfinder II (K80…	Teca, Inc.	1985	—
Kept off the family tree	K850881	FDA’s K850881 is Alba Dry Burn Pad Our OCR of the scanned summary read K850881, FDA’s number for Alba Dry Burn Pad (Alba Health Care). Its FDA name has none of the distinctive words the summary uses for the device it names, “Brain Mapper”. Kept off the family tree.	Alba Health Care	1985	—
*	K894889	Teca Neuromapper 386 Summary page 1 …al equivalence is based: Cordis Brain State Analyzer (no FDA information available), TECA Corporation Neurolab I, II (K844481), Brain Mapper (K850-881), Neuromapper 386 (K894889); Nicolet BEAM L 1I (no FDA 510(k) information available); Pathfinder II (K801604) Brain Functional Map (K843598); Cadwell Labora…	Teca, Inc.	1989	—
*	K801604	Pathfinder Electrodiagnostic System Summary page 1 …), TECA Corporation Neurolab I, II (K844481), Brain Mapper (K850-881), Neuromapper 386 (K894889); Nicolet BEAM L 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 T…	Nicolet Biomedical Instruments	1980	—
*	K843598	Brain Function Mapping Option for Pathf Summary page 1 …II (K844481), Brain Mapper (K850-881), Neuromapper 386 (K894889); Nicolet BEAM L 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 …romapper 386 (K894889); Nicolet BEAM L 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 …er 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., Madified 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., Madified Brain Atlas IT (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantifie…	Neuroscience, Inc.	1987	—
*	K854362	Modified Brain Atlas Iii Summary page 1 …24 (K904269), Neurosearch-4 (K920038); Neuroscience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation, Inc., Madified Brain Atlas IT (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QS1-9500 (K904294), QSI-9200 (FDA 510(k) informat…	Bio-Logic Systems Corp.	1986	—
*	K951594	Bio-Logic Automatic Event Analysis Summary page 1 …ience, Inc. Map-10 EEG (K840430), Neuromapper 1620 (K870263); Biologics Systems Corporation, Inc., Madified Brain Atlas IT (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QS1-9500 (K904294), QSI-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhy…	Bio-Logic Systems Corp.	1995	—
*	K904294	QSI 9500 Summary page 1 …K870263); Biologics Systems Corporation, Inc., Madified Brain Atlas IT (K854362), Bio-Logic Automatic Event Analysis (K951594); Quantified Signal Imaging, Inc. QS1-9500 (K904294), QSI-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhythm Software (K912938). (2)(4). Device Description:…	Quantified Signal Imaging, Inc.	1991	—
*	K912938	Rhythm Summary page 1 …ic Event Analysis (K951594); Quantified Signal Imaging, Inc. QS1-9500 (K904294), QSI-9200 (FDA 510(k) information not available); Stellate Systems, Inc. Rhythm Software (K912938). (2)(4). Device Description: The Neurometric Analysis System (NAS) is a software program for the post-hoc statistical analysis…	Stellate Systems	1991	—
*	—	Cordis Brain State Analyzer Named without a submission number			—
*	—	Nicolet BEAM L 1I Named without a submission number			—
*	—	Quantified Signal Imaging, Inc. QSI-9200 Named without a submission number			—

Also cleared against K844481: 1 other device →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K041263	Neuroguide Analysis System	Applied Neuroscience, Inc.	2004	21
K161068	Ahead 300	Brainscope Company, Inc.	2016	6
K050192	BRC Software Product	Brc Operations Pty Limited	2005	4
K112077	Hbidb - Human Brian Index Software	Corscience GmbH & Co. KG	2012	3

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?

None of the 13 ancestors has a recall.
Of its descendants, K041263 (Applied Neuroscience, Inc., 2004) has gone furthest, with 21 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?

The Neurometric Analysis System (NAS) is to be used by qualified medical professionals for the post-hoc 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/K974748 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974748: Neurometric Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974748

Report an extraction error

Are you the manufacturer?

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