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 Jul 27, 1989 after a 122-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jul 27, 1989
- Review
- 122 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK891920 AD-Tech's Depth ElectrodeAd-Tech Medical Instrument Corp · 1989
- Descendant · cites it directly · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · cites it directly · 12 of its ownK990788 AD-Tech's Foramen Ovale ElectrodeAd-Tech Medical Instrument Corp · 1999
- 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 · 2 generations on · 5 of its ownK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · cites it directly12descendants
- K990788AD-Tech's Foramen Ovale ElectrodeAd-Tech Medical Instrument Corp · 1999 · 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 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891920 | AD-Tech's Depth Electrode | Ad-Tech Medical Instrument Corp | 1989 | — |
| +1 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| +1 | K990788 | AD-Tech's Foramen Ovale Electrode | Ad-Tech Medical Instrument Corp | 1999 | — |
| +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 |
| +2 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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?
- 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/K891920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K891920: AD-Tech's Depth Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891920
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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