510(k) · Cleared
ClearedAD-Tech's Depth Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corp · GZL Electrode, Depth
Cleared on May 9, 1997 after a 190-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 190 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK964644 AD-Tech's Depth ElectrodeAd-Tech Medical Instrument Corp · 1997
- Descendant · cites it directly · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · cites it directly · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · 2 generations on · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · cites it directly12descendants
- K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · cites it directly11descendants
- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · 2 generations on5descendants
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · cites it directly5descendants
- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964644 | AD-Tech's Depth Electrode | Ad-Tech Medical Instrument Corp | 1997 | — |
| +1 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| +1 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +2 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| +1 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| +3 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041604 | Macro-Micro Depth Electrode | 2004 | 12 |
| K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes | 2006 | 11 |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer… | 2017 | 5 |
| K213170 | SENSOSEEG Depth Electrodes | 2023 | 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?
- Of its descendants, K041604 (Ad-Tech Medical Instrument Corp, 2004) has gone furthest, with 12 descendants of its own.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K964644 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964644: AD-Tech's Depth Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964644
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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