510(k) Report

510(k) · Cleared

Cleared

Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)

K250094510(k) TraditionalCleared Apr 14, 202590-day reviewClass II21 CFR 882.1310

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

Neuralynx, Inc. · GYC Electrode, Cortical

Cleared on Apr 14, 2025 as substantially equivalent to K180761 (Micromed S.P.A., 2018) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1984.

Decided
Apr 14, 2025
Review
90 days
Class
Class II
Product code
GYC
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K842956 (1984). 29 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2007: 1 other ancestor2009: 1 other ancestor2008: 3 other ancestors2000: 3 other ancestors1997: 1 other ancestor1993: 1 other ancestor2004: 1 other ancestor2002: 2 other ancestors1998: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor1995: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestorK842956 · Nicolet Viking · Nicolet Biomedical Instruments · 1984K971819 · Epoch 2000 Neurological Workstation · Axon Systems, Inc. · 1997K022785 · Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation · Axon Systems, Inc. · 2002K032741 · Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation · Axon Systems, Inc. · 2003K050798 · Eclipse Neurological Workstation · Axon Systems, Inc. · 2005K110410 · MS-120BK Electric Stimulator (Extension Unit) · Nihon Kohden Corp. · 2011K151354 · Cervello STIM · Blackrock Neuromed · 2016K180761 · SD LTM STIM Cortical Stimulator · Micromed S.P.A. · 201819801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors6 generations back: 3 other ancestors8 generations back: 3 other ancestors K180761 · SD LTM STIM Cortical Stimulator · Micromed S.P.A. · 2018K151354 · Cervello STIM · Blackrock Neuromed · 2016K110410 · MS-120BK Electric Stimulator (Extension Unit) · Nihon Kohden Corp. · 2011K050798 · Eclipse Neurological Workstation · Axon Systems, Inc. · 2005K032741 · Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation · Axon Systems, Inc. · 2003K022785 · Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation · Axon Systems, Inc. · 2002K971819 · Epoch 2000 Neurological Workstation · Axon Systems, Inc. · 1997K842956 · Nicolet Viking · Nicolet Biomedical Instruments · 1984−50
  1. Root · 8 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
  2. 7 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
  3. 6 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
  4. 5 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
  5. 4 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
  6. 3 generations backK110410 MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011
  7. 2 generations backK151354 Cervello STIMBlackrock Neuromed · 2016
  8. 1 generation backK180761 SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018
  9. This deviceK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K842956Nicolet VikingNicolet Biomedical Instruments1984—
−7K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc.1997—
−6K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc.2002—
−5K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc.2003—
−4K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005—
−3K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.2011—
−2K151354Cervello STIMBlackrock Neuromed2016—
−1K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.2018—
0 (this device)K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)…Neuralynx, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199310
199520
199710
199810
199910
200030
200220
200310
200410
200710
200830
200910
201810
FIG. 1 — Lineage of K250094, 1984–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 GYC? 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 GYC device

  1. #1 K191186 Subdural Strip/Intraoperative Split Electrode…score 11.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K180761SD LTM STIM Cortical Stimulator
Summary page 6
…ode K250094 Page 2 of 14 Device Class: Class II Predicate Device: K180761 SD LTM STIM Cortical Stimulator micromed S.p.A. 21 CFR 882.1310, G…
Micromed S.P.A.2018—
*K183123microTargeting Guideline 4000 5.0 System
Summary page 6
…SD LTM STIM Cortical Stimulator micromed S.p.A. 21 CFR 882.1310, GYC, Class II, Cortical electrode K183123 microTargeting Guideline 4000 5.0 System FHC, Inc. 21 CFR 882.1330…
FHC, Inc.20181

What descends from it?

No later submission names this one as a predicate yet.

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 41 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
  • 5 of the 29 ancestors have a recall of any class.

How does its category compare?

All GYC devices

GYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · GYC

2in 2025

2008: 22009: 22010: 12011: 12016: 12018: 22019: 22020: 22021: 12022: 22025: 2
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GYC

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

Recalls per year · GYC

1in 2013

2011: 32012: 1, 1 Class I2013: 1
2007high 3 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GYC

2in 2025

2007: 22008: 22009: 12010: 32011: 62012: 172013: 52014: 142015: 92016: 22017: 62018: 32019: 12020: 12021: 12022: 22023: 22024: 32025: 2
2007high 17 (2012) · low 1 (2009)2025

MAUDE reports naming product code GYC, 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
20070—02
20082—02
20092—01
20101—03
20111—36
20120—1 (1)17
20130—15
20140—014
20150—09
20161—02
20170—06
20182—03
20192—01
20202—01
20211—01
20222—02
20230—02
20240—03
20252—02
20260—0—

What is it indicated for?

The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial…

Read the full statement (124 words)

The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.

Indications for use as stated in the FDA summary.

More from Neuralynx, Inc.

2 FDA decisions under this applicant name. See the company

  • K110967Enterprise Electrophysiology SystemNeuralynx, Inc. · 2011

Recent decisions in GYC

The GYC category page

  • K242618Layer 7-TPrecision Neuroscience, Corp. · 2025
  • K221123WISE Cortical Strip (WCS)Wise S.R.L. · 2022
  • K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid…Spes Medica Srl · 2022
  • K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical · 2021
  • K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems · 2020

https://510kreport.com/device/K250094 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250094

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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