510(k) · Cleared
ClearedMicro Targeting Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FHC, Inc. · GZL Electrode, Depth
Cleared on Mar 24, 2004 as substantially equivalent to K991522 (FHC, Inc., 2000) and 2 other predicates after a 175-day review. Its family tree reaches back 3 generations to 1981. 16 later devices descend from it.
- Decided
- Mar 24, 2004
- Review
- 175 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811452 (1981). 6 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 2 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 1 generation backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- This deviceK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · 2 generations on · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · 3 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
- Descendant · 4 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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 · 2 generations on11descendants
- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · 3 generations on5descendants
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · 2 generations on5descendants
- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −2 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −1 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| 0 (this device) | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | 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 |
| +4 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K991522 | Microtargeting ElectrodeSummary page 2…tion of Legally Marketed Devices Name K Number Date Cleared FHC microTargeting® Electrodes K991522 Aug. 4, 2000 Radionics Semi-Microelectrode (SME) Kit K961858 Aug. 7, 1996 Microrecording Sy… | 2000 |
| * | K961858 | Cosgrove Depth Electrode Kit (Cdek)Summary page 2…Number Date Cleared FHC microTargeting® Electrodes K991522 Aug. 4, 2000 Radionics Semi-Microelectrode (SME) Kit K961858 Aug. 7, 1996 Microrecording Systems Consultants pEEG Pro System 5000 K991077… | 1996 |
| * | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000)Summary page 2…Radionics Semi-Microelectrode (SME) Kit K961858 Aug. 7, 1996 Microrecording Systems Consultants pEEG Pro System 5000 K991077 June 9, 2000 D. Description of Device The FHC microTargeting® Electrode is for intra-operative single unit record… | 1999 |
What descends from it? (16)
See all 164 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 23 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K041604 (Ad-Tech Medical Instrument Corp, 2004) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K991522.
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 FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033173 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033173: Micro Targeting Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033173
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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