510(k) · Cleared
ClearedSmartep, Model M010000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Hearing Systems · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jul 18, 2007 as substantially equivalent to K904926 (Intelligent Hearing Systems, 1991) and 2 other predicates after a 135-day review. Its family tree reaches back 2 generations to 1994. 16 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 135 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K934426 (1994). 4 ancestors in all, the oldest K890495 (1989). 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- 1 generation backK982595 NIM4Xomed, Inc. · 1998
- This deviceK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- Descendant · cites it directly · 12 of its ownK123843 Neuroepg SystemStrohl Medical Technologies · 2013
- Descendant · 2 generations on · 11 of its ownK132616 EPADSafeop Surgical, Inc. · 2014
- Descendant · 3 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 5 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123843Neuroepg SystemStrohl Medical Technologies · 2013 · cites it directly12descendants
- K132616EPADSafeop Surgical, Inc. · 2014 · 2 generations on11descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 3 generations on9descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 4 generations on4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| −1 | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| 0 (this device) | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| +1 | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
| +2 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
| +3 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +4 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +5 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 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 GWJ? 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 GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K904926 | Smart-EPSummary page 4…Nerve Stimulator/Monitor (per CFR 874.1820) Auditory Evoked Response Stimulator (per CFR 882.1900) Predicate Device(s): IHS SmartEP (K904926), Nicolet Viking II (K890495), Medtronic XOMED MIM-Response (K982595) D… | 1991 |
| * | K890495 | Nicolet Viking II SystemSummary page 4…Auditory Evoked Response Stimulator (per CFR 882.1900) Predicate Device(s): IHS SmartEP (K904926), Nicolet Viking II (K890495), Medtronic XOMED MIM-Response (K982595) Device Description: SmartEP is an evoked response… | 1989 |
| * | K982595 | NIM4Summary page 4…Predicate Device(s): IHS SmartEP (K904926), Nicolet Viking II (K890495), Medtronic XOMED MIM-Response (K982595) Device Description: SmartEP is an evoked response system that is capable of eliciting, acq… | 1998 |
What descends from it? (16)
See all 163 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 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K123843 (Strohl Medical Technologies, 2013) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K904926.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring. The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in…
Read the full statement (328 words)
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages 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, visual) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, 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 eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp 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 and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp 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/K070608 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070608: Smartep, Model M010000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070608
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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