510(k) · Cleared
ClearedNeuronav System and Neuronav Drive
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 Dec 3, 2007 after a 166-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 3, 2007
- Review
- 166 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK071697 Neuronav System and Neuronav DriveAlpha Omega, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK172042 NeuroNav System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK220553 Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK250601 Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K172042NeuroNav System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2018 · cites it directly2descendants
- K220553Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2022 · 2 generations on1descendant
- K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071697 | Neuronav System and Neuronav Drive | Alpha Omega, Ltd. | 2007 | — |
| +1 | K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2018 | — |
| +2 | K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2022 | — |
| +3 | K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172042 | NeuroNav System, NeuroSmart System | 2018 | 2 |
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?
- Of its descendants, K172042 (Alpha Omega Engineering, Ltd., 2018) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K071697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071697: Neuronav System and Neuronav Drive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071697
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026