510(k) · Cleared
ClearedNeuroepg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Strohl Medical Technologies · GWF Stimulator, Electrical, Evoked Response
Cleared on Jun 5, 2013 as substantially equivalent to K070608 (Intelligent Hearing Systems, 2007) after a 174-day review. Its family tree reaches back 3 generations to 1994. 12 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 174 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934426 (1994). 5 ancestors in all, the oldest K890495 (1989). 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- 2 generations backK982595 NIM4Xomed, Inc. · 1998
- 1 generation backK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- This deviceK123843 Neuroepg SystemStrohl Medical Technologies · 2013
- Descendant · cites it directly · 11 of its ownK132616 EPADSafeop Surgical, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132616EPADSafeop Surgical, Inc. · 2014 · cites it directly11descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 3 generations on4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 4 generations on3descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| −2 | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| −1 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| 0 (this device) | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
| +1 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +3 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +4 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K070608 | Smartep, Model M010000Summary page 1…2.1900) 18 years of age and older Hospital, clinic, EEG/EP technologist’s, sufgéon’s, or physician’s office, operating room ' None Intelligent Hearing System SmartEP (K070608) The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring, and measuring… | 2007 |
What descends from it? (12)
See all 122 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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132616 (Safeop Surgical, Inc., 2014) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K070608.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials. The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory…
Read the full statement (196 words)
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials.
The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory) and in surgical procedures for intraoperative monitoring.
The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery ear bud), and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123843: Neuroepg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123843
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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