510(k) · Cleared
ClearedCervello STIM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackrock Neuromed · GYC Electrode, Cortical
Cleared on Jan 27, 2016 as substantially equivalent to K072964 (Cardinal Health, Inc., 2008) and 3 other predicates after a 252-day review. Its family tree reaches back 6 generations to 1984. 2 later devices descend from it.
- Decided
- Jan 27, 2016
- Review
- 252 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K842956 (1984). 22 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 5 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 4 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 3 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 2 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 1 generation backK110410 MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp. · 2011
- This deviceK151354 Cervello STIMBlackrock Neuromed · 2016
- Descendant · cites it directly · 1 of its ownK180761 SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018
- Descendant · 2 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −5 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −4 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −3 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −2 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −1 | K110410 | MS-120BK Electric Stimulator (Extension Unit) | Nihon Kohden Corp. | 2011 | — |
| 0 (this device) | K151354 | Cervello STIM | Blackrock Neuromed | 2016 | — |
| +1 | K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018 | — |
| +2 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
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 K191186 Subdural Strip/Intraoperative Split Electrode…score 11.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K072964 | Nicolet Cortical StimulatorSummary page 4…YC Panel: Neurology 9. Reason for Traditional 510(k): New submission 10. Predicate Device(s): 510(k) Number: K072964 Manufacturer: Cardinal Health (Natus) Trade Name: Nicolet Cortica… | 2008 |
| * | K924226 | Ojemann Cortical StimulatorSummary page 4…Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310 Predicate Device(s): 510(k) Number: K924226 Manufacturer: Integra Life Sciences Trade Name: Ojemann Cortical… | 1993 |
| * | K110410 | MS-120BK Electric Stimulator (Extension Unit)Summary page 4…Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310 Predicate Device(s): 510(k) Number: K110410 Manufacturer: Nihon Khoden CERVELLO® STIM VOL_002… | 2011 |
| * | K082629 | S12X with Esax OptionSummary page 5…GYC (cortical electrodes), GWF (evoked response, electrical) Classification: 21 CFR 882.1310 Predicate Device(s): 510(k) Number: K082629 Manufacture: Grass Telefactor (Astromed) Trade Name: S12X… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180761 | SD LTM STIM Cortical Stimulator | 2018 | 1 |
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 32 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K180761 (Micromed S.P.A., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K072964.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GYC
2in 2025
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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYC
2in 2025
MAUDE reports naming product code GYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 3 | 6 |
| 2012 | 0 | — | 1 (1) | 17 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical 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 Cervello®…
Read the full statement (112 words)
The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical 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 Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151354: Cervello STIM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151354
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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