510(k) · Cleared
ClearedNeuroNav System, NeuroSmart System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha Omega Engineering, Ltd. · GZL Electrode, Depth
Cleared on Feb 27, 2018 as substantially equivalent to K071697 (Alpha Omega, Ltd., 2007) after a 236-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Feb 27, 2018
- Review
- 236 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071697 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK071697 Neuronav System and Neuronav DriveAlpha Omega, Ltd. · 2007
- This deviceK172042 NeuroNav System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK220553 Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK250601 Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071697 | Neuronav System and Neuronav Drive | Alpha Omega, Ltd. | 2007 | — |
| 0 (this device) | K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2018 | — |
| +1 | K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2022 | — |
| +2 | K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K071697 | Neuronav System and Neuronav DriveSummary page 4…21 CFR §882.1330 Regulatory Class: II Identification of Legally Marketed Predicate Devices NeuroNav System and NeuroNav Drive device - K071697 Page 1 of 13 Alpha Omega Engineering Ltd. Mount Precipice 2015 P.O. Box 2268 Naz… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220553 | Neuro Omega System, NeuroSmart System | 2022 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K220553 (Alpha Omega Engineering, Ltd., 2022) has gone furthest, with 1 descendant 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. 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 NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172042: NeuroNav System, NeuroSmart System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172042
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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