510(k) · Cleared
ClearedNeurotrek Physiological Navigation System for Neurosurgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha Omega, Ltd. · GZL Electrode, Depth
Cleared on Jan 24, 2000 as substantially equivalent to K970943 (Axon Instruments, Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Jan 24, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970943 (1997). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970943 Guideline SystemAxon Instruments, Inc. · 1997
- This deviceK993622 Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK071364 Microtargeting Guideline 4000FHC, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK183123 microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140680 Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014
Most influential descendants
Showing 4 of 4 · See all- K071364Microtargeting Guideline 4000FHC, Inc. · 2007 · cites it directly3descendants
- K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · 2 generations on1descendant
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · 3 generations on0descendants
- K140680Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| 0 (this device) | K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | 2000 | — |
| +1 | K071364 | Microtargeting Guideline 4000 | FHC, Inc. | 2007 | 1 |
| +2 | K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018 | 1 |
| +3 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 2…logy panel. 11-3 Predicate Devices: The NeuroTrek system is substantially equivalent to: e Guideline System 3000 (Axon Instruments, Inc), cleared under K970943. ¢ NeuroMap (RADIONICS), cleared under K981820. Performance Standards: No performance standards have been established for such… | 1997 |
| * | K981820 | NeuromapSummary page 2…ices: The NeuroTrek system is substantially equivalent to: e Guideline System 3000 (Axon Instruments, Inc), cleared under K970943. ¢ NeuroMap (RADIONICS), cleared under K981820. Performance Standards: No performance standards have been established for such devices under Sections 514 of the Federal Food,… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071364 | Microtargeting Guideline 4000 | 2007 | 3 |
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?
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?
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
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/K993622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993622: Neurotrek Physiological Navigation System for Neurosurgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993622
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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