510(k) Report

510(k) · Cleared

Cleared

Neurolink Eeg/EP/Emg Surface Electrodes

K942921510(k) TraditionalCleared Jan 31, 1995224-day reviewClass II21 CFR 882.1320

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

Neuro Supplies, Inc. · GXY Electrode, Cutaneous

Cleared on Jan 31, 1995 after a 224-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 51 later devices descend from it.

Decided
Jan 31, 1995
Review
224 days
Class
Class II
Product code
GXY
Recalls
None
Predicates
0

51 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2012: 2 descendants cleared2007: 1 descendant cleared2013: 3 descendants cleared2017: 7 descendants cleared2020: 1 descendant cleared2019: 5 descendants cleared2026: 6 descendants cleared2014: 3 descendants cleared2015: 2 descendants cleared2023: 4 descendants cleared2018: 3 descendants cleared2022: 4 descendants cleared2024: 3 descendants cleared2025: 3 descendants cleared2016: 1 descendant cleared2021: 2 descendants cleared1995200020052010201520202025
  1. This deviceK942921 Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc. · 1995
  2. Descendant · cites it directly · 50 of its ownK061148 Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006
  3. Descendant · 2 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
  4. Descendant · 3 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
  5. Descendant · 4 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
  6. Descendant · 5 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12012: 22013: 32014: 32015: 22016: 12017: 72018: 32019: 52020: 12021: 22022: 42023: 42024: 32025: 32026: 6
2006high 7 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 51 · See all
  • K061148Rhythmlink Disc ElectrodesRhythmlink International, LLC · 2006 · cites it directly50descendants
  • K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 2 generations on35descendants
  • K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 3 generations on33descendants
  • K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 4 generations on24descendants
  • K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 5 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942921Neurolink Eeg/EP/Emg Surface ElectrodesNeuro Supplies, Inc.1995—
+1K061148Rhythmlink Disc ElectrodesRhythmlink International, LLC2006—
+2K112718Nuvasive NVM5 SystemNuvasive, Inc.2012—
+3K123307Nuvasive NVM5 SystemNuvasive, Inc.2013—
+4K132694Nuvasive NVM5 SystemNu Vasive, Incorporated2014—
+5K141968Nuvasive NVM5 SystemNuvasive, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201220
201330
201430
201520
201610
201770
201830
201950
202010
202120
202240
202340
202430
202530
202660
FIG. 1 — Lineage of K942921, 1995–2026Source: 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 GXY? 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 GXY device

  1. #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (51)

See all 51

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061148Rhythmlink Disc ElectrodesRhythmlink International, LLC200650

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, K061148 (Rhythmlink International, LLC, 2006) has gone furthest, with 50 descendants of its own.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXY

6in 2025

2007: 72008: 92009: 172010: 32011: 62012: 92013: 72014: 92015: 62016: 62017: 92018: 142019: 92020: 42021: 122022: 52023: 132024: 72025: 62026 (partial year): 12
2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007: 88 days median2008: 136 days median2009: 159 days median2010: 137 days median2011: 183 days median2012: 150 days median2013: 99 days median2014: 203 days median2015: 119 days median2016: 170 days median2017: 116 days median2018: 135 days median2019: 113 days median2020: 108 days median2021: 195 days median2022: 81 days median2023: 132 days median2024: 111 days median2025: 148 days median2026 (partial year): 70 days median
2007high 203 (2014) · low 81 (2022)2026

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

Recalls per year · GXY

2in 2023

2009: 42010: 12011: 52012: 42023: 2
2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · GXY

58in 2025

2007: 142008: 172009: 152010: 142011: 162012: 162013: 152014: 112015: 192016: 152017: 112018: 102019: 192020: 112021: 212022: 342023: 252024: 512025: 58
2007high 58 (2025) · low 10 (2018)2025

MAUDE reports naming product code GXY, 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
2007788014
20089136017
200917159415
20103137114
20116183516
20129150416
2013799015
20149203011
20156119019
20166170015
20179116011
201814135010
20199113019
20204108011
202112195021
2022581034
202313132225
20247111051
20256148058
202612700—

More from Neuro Supplies, Inc.

5 FDA decisions under this applicant name. See the company

  • K991769Cutaneous (Bar) ElectrodeNeuro Supplies, Inc. · 1999
  • K991770Cutaneous (Ground) ElectrodeNeuro Supplies, Inc. · 1999
  • K991772Cutaneous (Disc) ElectrodeNeuro Supplies, Inc. · 1999
  • K991771Digital Ring ElectrdeNeuro Supplies, Inc. · 1999

Recent decisions in GXY

The GXY category page

  • K262664Rongjian Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd. · 2026
  • K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026
  • K261522BioWave BioWrapsBiowave Corporation · 2026

https://510kreport.com/device/K942921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942921: Neurolink Eeg/EP/Emg Surface Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942921

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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