510(k) · Cleared
ClearedEvo sEEG System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroone Medical Technologies Corp. · GZL Electrode, Depth
Cleared on Sep 1, 2021 as substantially equivalent to K170959 (Dixi Medical, 2017) after a 120-day review. Its family tree reaches back 7 generations to 1981. 2 later devices descend from it.
- Decided
- Sep 1, 2021
- Review
- 120 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K811452 (1981). 18 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 6 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 5 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 4 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 3 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 2 generations backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- 1 generation backK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- This deviceK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · cites it directly · 1 of its ownK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 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 |
|---|---|---|---|---|---|
| −7 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −6 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −5 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −4 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −3 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −2 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| −1 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| 0 (this device) | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +1 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
| +2 | K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode… | Beijing Sinovation Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 GZL? 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K170959 | DIXI Medical Microdeep Depth ElectrodeSummary page 5…Subject Device Predicate Device K211367 K170959 DIXI Medical Microdeep Depth Trade/Device Name:… | 2017 |
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 |
|---|---|---|---|
| K222404 | Evo® sEEG System | 2022 | 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 40 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K222404 (Neuroone Medical Technologies Corp., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K170959.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Evo sEEG System is intended for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211367: Evo sEEG System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211367
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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