510(k) · Cleared
Recalled · 2009Microtargeting Guideline 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FHC, Inc. · GZL Electrode, Depth
Cleared on Jul 25, 2007 as substantially equivalent to K970943 (Axon Instruments, Inc., 1997) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970943 (1997). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970943 Guideline SystemAxon Instruments, Inc. · 1997
- 1 generation backK993622 Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000
- This deviceK071364 Microtargeting Guideline 4000FHC, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK183123 microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK140680 Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014
Most influential descendants
Showing 3 of 3 · See all- K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · cites it directly1descendant
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · 2 generations on0descendants
- K140680Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| −1 | K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | 2000 | — |
| 0 (this device) | K071364 | Microtargeting Guideline 4000 | FHC, Inc. | 2007 | — |
| +1 | K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018 | 1 |
| +2 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
| +1 | K140680 | Leadpoint Focus Workststion, Leadpoint Focus Notebook System | Alpine Biomed Aps | 2014 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K970943 | Guideline SystemSummary page 1…vice F. Classification Name: Depth electrode (21 CFR 882.1330, Product Code GZL) G. Substantially Equivalent To: 1.Axon Instruments, Inc. Guideline System 3000 (K970943; decision date: Aug. 18, 1997) 2. Alpha Omega Neurotrek Physiological Navigation System (K993622; decision date: Jan. 24, 2000… | 1997 |
| * | K993622 | Neurotrek Physiological Navigation System for NeurosurgerySummary page 1…lly Equivalent To: 1.Axon Instruments, Inc. Guideline System 3000 (K970943; decision date: Aug. 18, 1997) 2. Alpha Omega Neurotrek Physiological Navigation System (K993622; decision date: Jan. 24, 2000) H. Description: The microTargeting® Guideline 4000 is designed for intraoperative electrophys… | 2000 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Dec 28, 2009 | Not classified | Z-1143-2010 | Software change control | The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183123 (FHC, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K970943.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071364: Microtargeting Guideline 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071364
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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