510(k) · Cleared
Recalled · 2008Microtargeting 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 Aug 4, 2000 as substantially equivalent to K991077 (Microrecording Systems Consultants, LLC, 1999) and 2 other predicates after a 459-day review. Its family tree reaches back 2 generations to 1981. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 4, 2000
- Review
- 459 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K811452 (1981). 5 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 1 generation backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- This deviceK991522 Microtargeting ElectrodeFHC, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · 3 generations on · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · 4 generations on · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- Descendant · 3 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 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K033173Micro Targeting ElectrodeFHC, Inc. · 2004 · cites it directly16descendants
- K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · 2 generations on12descendants
- K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · 3 generations on11descendants
- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · 4 generations on5descendants
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −1 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| 0 (this device) | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | — |
| +1 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| +2 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| +3 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +4 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| +3 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
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 | 3 | 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 |
|---|---|---|---|
| * | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000) Cleared while this submission was under review Summary page 2…world’s best!” /,% > C. Identification of Legally Marketed Devices 1. Name: LEEG ProSystem Pali-Trode Radionics SME 5000 Depth Electrode 2. K Number: K991077 K981015 K961858 3. Date Cleared: June 9, 1999 June 16, 1998 August 7, 1996 D. Description of the Device The microTargeting™ Ele… | 1999 |
| * | K981015 | Pali-TrodeSummary page 2…best!” /,% > C. Identification of Legally Marketed Devices 1. Name: LEEG ProSystem Pali-Trode Radionics SME 5000 Depth Electrode 2. K Number: K991077 K981015 K961858 3. Date Cleared: June 9, 1999 June 16, 1998 August 7, 1996 D. Description of the Device The microTargeting™ Electrodes… | 1998 |
| * | K961858 | Cosgrove Depth Electrode Kit (Cdek)Summary page 2…/,% > C. Identification of Legally Marketed Devices 1. Name: LEEG ProSystem Pali-Trode Radionics SME 5000 Depth Electrode 2. K Number: K991077 K981015 K961858 3. Date Cleared: June 9, 1999 June 16, 1998 August 7, 1996 D. Description of the Device The microTargeting™ Electrodes (K991522… | 1996 |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2008 | Not classified | Z-0499-2009 | Pending | Mislabeled: May contain an electrode longer than labeled size |
| Oct 20, 2008 | Not classified | Z-0497-2009 | Pending | Mislabeled: May contain an electrode longer than labeled size |
| Oct 20, 2008 | Not classified | Z-0498-2009 | Pending | Mislabeled: May contain an electrode longer than labeled size |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K033173 (FHC, Inc., 2004) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K991077.
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 microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in 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/K991522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991522: Microtargeting Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991522
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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