510(k) · Cleared
Recalled · Class II · 2020microTargeting Guideline 4000 5.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FHC, Inc. · GZL Electrode, Depth
Cleared on Dec 20, 2018 as substantially equivalent to K071364 (FHC, Inc., 2007) after a 37-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2018
- Review
- 37 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970943 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970943 Guideline SystemAxon Instruments, Inc. · 1997
- 2 generations backK993622 Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000
- 1 generation backK071364 Microtargeting Guideline 4000FHC, Inc. · 2007 · Recalled
- This deviceK183123 microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| −2 | K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | 2000 | — |
| −1 | K071364 | Microtargeting Guideline 4000 | FHC, Inc. | 2007 | 1 |
| 0 (this device) | K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018 | — |
| +1 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K071364 | Microtargeting Guideline 4000Summary page 4…laims substantial equivalence: The microtargeting™ Guideline 4000™ 5.0 System is substantially equivalent to FHC, Inc.’s microTargeting® Guideline 4000 (K071364); decision date: July 25th 2007, product code: GZL. FHC Corporate & Manufacturing Tel: +1-207-666-8190 FHC Europe… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2020 | Class II | Z-2540-2020 | Component change control | An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K250094 (Neuralynx, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071364.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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™ Guideline 4000 5.0 System is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183123: microTargeting Guideline 4000 5.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183123
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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