510(k) · Cleared
Recalled · Class I · 2018Neuro Omega 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 Apr 5, 2013 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Apr 5, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 1 (1 Class I)
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- This deviceK123796 Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK171581 Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · Recalled (Class I)
- 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
Class I recalls in this family
- K171581 Neuro Omega Systemcites it directly · 2017
Most influential descendants
Showing 3 of 3 · See all- K171581Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · 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) | K123796 | Neuro Omega System | Alpha Omega Engineering, Ltd. | 2013 | — |
| +1 | K171581 | Neuro Omega System | Alpha Omega Engineering, Ltd. | 2017 | Class I |
| +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 |
|---|---|---|
| 2017 | 1 | 1 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K171581 | Neuro Omega System Class I | 2017 | 2 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2018 | Class I | Z-1216-2019 | Device Design | If cables are improperly connected, current may reach high charge density, causing tissue harm. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K171581Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K171581 (Alpha Omega Engineering, Ltd., 2017) 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. 2013, 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 Neuro Omega System, including the NeuroDrive unit, is intended to assist 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 electrodes. The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical…
Read the full statement (163 words)
The Neuro Omega System, including the NeuroDrive unit, is intended to assist 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 electrodes.
The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123796 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123796: Neuro Omega System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123796
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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