510(k) Report

510(k) · Cleared

Cleared

Neurosearch-24 or NRS-24

K904269510(k) TraditionalCleared Jun 4, 1991259-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

Lexicor Medical Technology, Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Jun 4, 1991 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.

Decided
Jun 4, 1991
Review
259 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

30 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared1998: 1 descendant cleared2020: 2 descendants cleared2014: 1 descendant cleared2005: 1 descendant cleared2018: 3 descendants cleared2023: 3 descendants cleared2012: 2 descendants cleared2009: 1 descendant cleared2024: 2 descendants cleared2016: 2 descendants cleared2013: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2025: 2 descendants cleared2019: 2 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK904269 Neurosearch-24 or NRS-24Lexicor Medical Technology, Inc. · 1991
  2. Descendant · cites it directly · 29 of its ownK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
  3. Descendant · cites it directly · 21 of its ownK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
  4. Descendant · 2 generations on · 9 of its ownK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
  5. Descendant · 3 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
  6. Descendant · 2 generations on · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12005: 12009: 12010: 12012: 22013: 12014: 12015: 12016: 22017: 12018: 32019: 22020: 22022: 12023: 32024: 22025: 22026: 2
1998high 3 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 30 · See all
  • K974748Neurometric Analysis SystemNxlink, Ltd. · 1998 · cites it directly29descendants
  • 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 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904269Neurosearch-24 or NRS-24Lexicor Medical Technology, Inc.1991—
+1K974748Neurometric Analysis SystemNxlink, Ltd.1998—
+1K041263Neuroguide Analysis SystemApplied Neuroscience, Inc.2004—
+2K092039Identevent, Version 1.0GOptima Neuroscience, Inc.2009—
+3K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.2010—
+2K161068Ahead 300Brainscope Company, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200510
200910
201010
201220
201310
201410
201510
201620
201710
201830
201920
202020
202210
202330
202420
202520
202620
FIG. 1 — Lineage of K904269, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in GWQ? 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 GWQ device

  1. #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K974748Neurometric Analysis SystemNxlink, Ltd.199829
K041263Neuroguide Analysis SystemApplied Neuroscience, Inc.200421

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, K974748 (Nxlink, Ltd., 1998) has gone furthest, with 29 descendants of its own.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007: 12008: 22010: 32011: 42012: 42013: 22014: 22015: 32016: 32017: 52018: 82020: 62022: 32023: 62024: 12026 (partial year): 2
2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2010: 73 days median2011: 220 days median2012: 208 days median2015: 276 days median2016: 50 days median2017: 181 days median2018: 150 days median2020: 216 days median2022: 216 days median2023: 137 days median
2007high 276 (2015) · low 50 (2016)2026

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

Recalls per year · GWQ

1in 2020

2007: 52008: 22009: 12010: 12015: 22019: 22020: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2011)2026

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

Adverse event reports per year · GWQ

13in 2025

2007: 112008: 82009: 72010: 122011: 62012: 92013: 42014: 72015: 132016: 282017: 172018: 152019: 162020: 302021: 202022: 162023: 202024: 172025: 13
2007high 30 (2020) · low 4 (2013)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—511
20082—28
20090—17
2010373112
2011422006
2012420809
20132—04
20142—07
20153276213
2016350028
20175181017
20188150015
20190—216
20206216130
20210—020
20223216016
20236137020
20241—017
20250—013
20262—1—
Cite this page

510(k) Report. “K904269: Neurosearch-24 or NRS-24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904269

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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