510(k) · Cleared
Recalled · Class II · 2026SafeOp 3: Neural Informatix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Jan 11, 2026 as substantially equivalent to K234092 (Alphatec Spine, Inc., 2024) after a 125-day review. Its family tree reaches back 9 generations to 1984. It has been recalled once.
- Decided
- Jan 11, 2026
- Review
- 125 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K842956 (1984). 62 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 5 generations between
- 3 generations backK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- 2 generations backK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- 1 generation backK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- This deviceK252842 SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 8 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 7 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 6 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 5 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 4 generations backK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- 3 generations backK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- 2 generations backK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- 1 generation backK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- This deviceK252842 SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −8 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −7 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −6 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −5 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −4 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| −3 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| −2 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| −1 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| 0 (this device) | K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 4 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 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 |
|---|---|---|---|
| * | K234092 | SafeOp 3: Neural Informatix SysteemSummary page 5…, ETN C. LEGALLY MARKETED PREDICATE DEVICES Primary Predicate: 510(k) Product Name Clearance Date K234092 SafeOp 3TM: Neural Informatix System 04/19/2024 D. DEVICE DESCRIPTION The SafeOpTM 3: Neur… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2026 | Class II | Z-2793-2026 | Software Design Change | Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 62 ancestors have a recall of any class.
- 1 other device also cites its predicate K234092.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation…
Read the full statement (107 words)
The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.
SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252842: SafeOp 3: Neural Informatix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252842
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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