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 Dec 22, 2017 as substantially equivalent to K123796 (Alpha Omega Engineering, Ltd., 2013) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 1993. 2 of the 7 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 22, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924226 (1993). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK924226 Ojemann Cortical StimulatorRadionics, Inc. · 1993 · Recalled
- 1 generation backK072964 Nicolet Cortical StimulatorCardinal Health, Inc. · 2008 · Recalled
- This deviceK171581 Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2017
- 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
Class I recalls in this family
- K123796 Neuro Omega Systemdirect predicate · 2013
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 |
|---|---|---|---|---|---|
| −2 | K924226 | Ojemann Cortical Stimulator | Radionics, Inc. | 1993 | 1 |
| −1 | K072964 | Nicolet Cortical Stimulator | Cardinal Health, Inc. | 2008 | 3 |
| 0 (this device) | K171581 | Neuro Omega System | Alpha Omega Engineering, Ltd. | 2017 | — |
| +1 | K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering, Ltd. | 2022 | — |
| +2 | 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 |
| 2013 | 1 | 1 |
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.
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? (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 |
|---|---|---|---|
| * | K123796 | Neuro Omega SystemSummary page 4…CFR §882.1330 Regulatory Class: II Identification of Legally Marketed Predicate Devices Neuro Omega System - K123796 For cortical recording and stimulation Nicolet Cortical Stimulator - K072964… | 2013 |
| * | K072964 | Nicolet Cortical StimulatorSummary page 4…Devices Neuro Omega System - K123796 For cortical recording and stimulation Nicolet Cortical Stimulator - K072964 Page 1 of 18 Alpha Omega Engineering Ltd. Mount Precipice 2015 P.O. Box 2268 Na… | 2008 |
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? (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.
- K123796Neuro Omega SystemAlpha Omega Engineering, Ltd. · 2013 · Direct predicate · ◆ in the 2013 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I 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. 2017, 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 subject device, the Neuro Omega System incorporated the installed 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 subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended: -To monitor, record and…
Read the full statement (219 words)
The subject device, the Neuro Omega System incorporated the installed 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 subject device, the Neuro Omega System incorporated the installed 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 seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, 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 summary.
https://510kreport.com/device/K171581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171581: Neuro Omega System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171581
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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