510(k) · Cleared
ClearedS12X with Esax Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chatten Associates, Inc. · GYC Electrode, Cortical
Cleared on Jul 1, 2009 as substantially equivalent to K924226 (Radionics, Inc., 1993) and 2 other predicates after a 295-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 295 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944678 (1995). 5 ancestors in all, the oldest K924226 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- 2 generations backK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- 1 generation backK073491 Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008
- This deviceK082629 S12X with Esax OptionChatten Associates, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK151354 Cervello STIMBlackrock Neuromed · 2016
- Descendant · 2 generations on · 1 of its ownK180761 SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018
- Descendant · 3 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK173684 g.Estim PROG.Tec Medical Engineering GmbH · 2018
Most influential descendants
Showing 4 of 4 · See all- K151354Cervello STIMBlackrock Neuromed · 2016 · cites it directly2descendants
- K180761SD LTM STIM Cortical StimulatorMicromed S.P.A. · 2018 · 2 generations on1descendant
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · 3 generations on0descendants
- K173684g.Estim PROG.Tec Medical Engineering GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| −2 | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| −1 | K073491 | Eeg-1100A Switch Box | Nihon Kohden America, Inc. | 2008 | — |
| 0 (this device) | K082629 | S12X with Esax Option | Chatten Associates, Inc. | 2009 | — |
| +1 | K151354 | Cervello STIM | Blackrock Neuromed | 2016 | — |
| +2 | K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018 | — |
| +3 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
| +1 | K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K924226 | Ojemann Cortical StimulatorSummary page 1…ical Stimulator with Switching Unit Product Classification: Category: Electrode, Cortical (based on Predicate Device Ojemann Cortical Stimulator #K924226) Regulation Number: 882.1310 (based on Predicate Device Ojemann Cortical Stimulator#K924226) Product Co… | 1993 |
| * | K040360 | EMU128S, Model EX-NW-128SSummary page 1…l Equivalence to: * Oiemann Cortical Stimulator (K924226), Radionics/Integra Lifesciences Corporation, Plainsboro, NJ * EMU128S, MODEL EX-NW128S (K040360), Excel Tech, LTD (XLTEK), Oakville, ONT, Canada; now a division of Natus Medical, Inc., San Carlos, CA… | 2004 |
| * | K073491 | Eeg-1100A Switch BoxSummary page 1…S (K040360), Excel Tech, LTD (XLTEK), Oakville, ONT, Canada; now a division of Natus Medical, Inc., San Carlos, CA * EEG-1100A Switch Box (K073491), Nihon Kohden America, Inc., Foothill Ranch, CA * S12 Cortical Stimulator, marketed prior to May 28, 1976 and sold a… | 2008 |
| * | — | S12 Cortical Stimulator Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K151354 (Blackrock Neuromed, 2016) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K924226.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 S12X Cortical Stimulator is intended for Intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of essential cortex. The device is intended for use only by medically trained and qualified personnel, within a hospital or medical environment. The ESAx option is intended for use with the S12X for facilitating the switching of the patient electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082629: S12X with Esax Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082629
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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