510(k) · Cleared
ClearedNeuro Omega 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 Mar 30, 2025 as substantially equivalent to K220553 (Alpha Omega Engineering, Ltd., 2022) after a 30-day review. Its family tree reaches back 4 generations to 1993. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 30, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924226 (1993). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK924226 Ojemann Cortical StimulatorRadionics, Inc. · 1993 · Recalled
- 3 generations backK072964 Nicolet Cortical StimulatorCardinal Health, Inc. · 2008 · Recalled
- 2 generations backK171581 Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017 · Recalled (Class I)
- 1 generation backK220553 Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2022
- This deviceK250601 Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering, Ltd. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924226 | Ojemann Cortical Stimulator | Radionics, Inc. | 1993 | 1 |
| −3 | K072964 | Nicolet Cortical Stimulator | Cardinal Health, Inc. | 2008 | 3 |
| −2 | K171581 | Neuro Omega System | Alpha Omega Engineering, Ltd. | 2017 | Class I |
| −1 | K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2022 | — |
| 0 (this device) | K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 1 |
| 2018 | 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.
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? (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 |
|---|---|---|---|
| * | K220553 | Neuro Omega System, NeuroSmart SystemSummary page 6…= Page 6 === 1 Identification of Legally Marketed Predicate Devices • Neuro Omega/NeuroSmart systems incorporated with HaGuide Software (as cleared under K220553) 2 Device Description – HaGuide Software The cleared devices under K220553, the HaGuide Software incorporated in Neuro Omega/N… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 4 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Neuro Omega System: The Neuro Omega System with the incorporated HaGuide Software, including the Drive Headstage 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 with the incorporated HaGuide Software is also intended: - To monitor, record, and display the bioelectric…
Read the full statement (273 words)
Neuro Omega System:
The Neuro Omega System with the incorporated HaGuide Software, including the Drive Headstage 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 with the incorporated HaGuide Software 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).
- To measure, record, and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
- To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
- To provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during treatment of patients with a seizure disorder.
The Neuro Omega System with the incorporated installed HaGuide Software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
NeuroSmart System:
The NeuroSmart System with the incorporated HaGuide Software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250601: Neuro Omega 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/K250601
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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