510(k) · Cleared
ClearedSafeOp 2: 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 Mar 9, 2022 as substantially equivalent to K182542 (Safeop Surgical, Inc., 2019) after an 89-day review. Its family tree reaches back 7 generations to 1984. 4 later devices descend from it.
- Decided
- Mar 9, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K842956 (1984). 60 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 6 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 5 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 4 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 3 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 2 generations backK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- 1 generation backK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- This deviceK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252842 SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 2026 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · cites it directly3descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 3 generations on0descendants
- K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −6 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −5 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −4 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −3 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −2 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| −1 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| 0 (this device) | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +1 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +3 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
| +2 | K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K182542 | The EPAD 2 SystemSummary page 4…II. LEGALLY MARKETED PREDICATE DEVICES Primary Predicate: 510(k) Product Name Clearance Date K182542 EPAD™ 2 System February 2019… | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234092 | SafeOp 3: Neural Informatix Systeem | 2024 | 3 |
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?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 60 ancestors have a recall of any class.
- Of its descendants, K234092 (Alphatec Spine, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K182542.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 2: Neural Informatix System is intended for use in monitoring neurological status by recording 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213849: SafeOp 2: 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/K213849
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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