510(k) · Cleared
ClearedThe EPAD 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safeop Surgical, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Feb 22, 2019 as substantially equivalent to K132616 (Safeop Surgical, Inc., 2014) and 4 other predicates after a 158-day review. Its family tree reaches back 6 generations to 1984. 9 later devices descend from it.
- Decided
- Feb 22, 2019
- Review
- 158 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K842956 (1984). 59 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 5 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 4 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 3 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 2 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 1 generation backK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- This deviceK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · cites it directly4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 2 generations on3descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · cites it directly3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −5 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −4 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −3 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −2 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −1 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| 0 (this device) | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +1 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +1 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +3 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K132616 | EPADSummary page 4…I. LEGALLY MARKETED PREDICATE DEVICES Primary Predicate: 510(k) Product Name Clearance Date K132616 EPAD™ (Evoked Potential Assessing Device) January 24, 2014 Additional Predicates: 510(k)… | 2014 |
| * | K083124 | NIM 3.0Summary page 4…vice) January 24, 2014 Additional Predicates: 510(k) Product Name Clearance Date K083124 Nerve Integrity Monitor 3.0 February 27, 2009 Eclipse TCD Neurovascular W… | 2009 |
| * | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Summary page 4…K083124 Nerve Integrity Monitor 3.0 February 27, 2009 Eclipse TCD Neurovascular Workstation Eclipse K061639 Neurological Workstation with TCD and vascular November 1, 2006 Doppler CardioM… | 2006 |
| * | K110410 | MS-120BK Electric Stimulator (Extension Unit)Summary page 4…ion Eclipse K061639 Neurological Workstation with TCD and vascular November 1, 2006 Doppler CardioMon K110410 MS-120BK Electric Stimulator Extension Unit August 4, 2011 K162383 Cadwell Sierra Su… | 2011 |
| * | K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentSummary page 4…mber 1, 2006 Doppler CardioMon K110410 MS-120BK Electric Stimulator Extension Unit August 4, 2011 K162383 Cadwell Sierra Summit March 1, 2017 Page 1… | 2017 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 35 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 6 of the 59 ancestors have a recall of any class.
- Of its descendants, K213849 (Alphatec Spine, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K132616.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 EPAD 2 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 or percutaneous lumbar, thoracic, and cervical surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182542: The EPAD 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182542
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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