510(k) · Cleared
ClearedDepth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes
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 25, 2006 as substantially equivalent to K891920 (Ad-Tech Medical Instrument Corp, 1989) and 5 other predicates after a 174-day review. Its family tree reaches back 5 generations to 1981. 11 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 174 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K811452 (1981). 13 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 4 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 3 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 2 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 1 generation backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- This deviceK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · cites it directly · 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 · 2 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · 2 generations on · 1 of its ownK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · cites it directly5descendants
- 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 · 2 generations on2descendants
- K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023 · 2 generations on1descendant
- K222404Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −4 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −3 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −2 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −1 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| 0 (this device) | 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 |
| +1 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| +2 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +2 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
| +3 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
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 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (6)
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 |
|---|---|---|---|
| * | K891920 | AD-Tech's Depth ElectrodeSummary page 1…Common Name: Depth Electrodes Classification Name: 21 CFR 882.1330, Depth Electrode Predicate Device(s): 5 10(k) Number: K891920, K964644 Manufacture: AD-TECH Medical Instrument Corporation Trade Name:… | 1989 |
| * | K964644 | AD-Tech's Depth ElectrodeSummary page 1…Name: Depth Electrodes Classification Name: 21 CFR 882.1330, Depth Electrode Predicate Device(s): 5 10(k) Number: K891920, K964644 Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Depth El… | 1997 |
| * | K990788 | AD-Tech's Foramen Ovale ElectrodeSummary page 1…Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Depth Electrode 510(k) Number: K990788 Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Foramen… | 1999 |
| * | K041604 | Macro-Micro Depth ElectrodeSummary page 1…Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Foramen Ovale Depth Electrode 510(k) Number: K041604 Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Macro-Mi… | 2004 |
| * | K861031 | Wyler Sphenoidal ElectrodeSummary page 1…Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Macro-Micro Depth Electrode 510(k) Number: K861031 Manufacture: AD-TECH Medical Instrument Corporation Trade Name: Wyler Sp… | 1986 |
| * | K042384 | Neuroport Recording Microelectrode Array SystemSummary page 1…anufacture: AD-TECH Medical Instrument Corporation Trade Name: Wyler Sphenoidal Depth Electrode 510(k) Number: K042384 Manufacture: Cyberkinetics, Inc. Trade Name: NeuroPort TM Cortical Micro… | 2005 |
What descends from it? (11)
See all 112 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 25 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K170959 (Dixi Medical, 2017) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K891920.
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 | — |
What is it indicated for?
The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053358
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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