510(k) · Cleared
ClearedSmartEP
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 Sep 29, 2017 as substantially equivalent to K070608 (Intelligent Hearing Systems, 2007) and 1 other predicate after a 305-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Sep 29, 2017
- Review
- 305 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002985 (2000). 11 ancestors in all, the oldest K890495 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- 4 generations backK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- 3 generations backK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009 · Recalled
- 2 generations backK092373 Ics Chartr EP 200Gn Otometrics · 2009
- 1 generation backK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- This deviceK163326 SmartEPIntelligent Hearing Systems · 2017
- Descendant · cites it directly · 0 of its ownK193033 GSI Audera ProGrason Stadler · 2020
Most influential descendants
Showing 1 of 1 · See all- K193033GSI Audera ProGrason Stadler · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| −4 | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae Systems | Ics Medical | 2003 | — |
| −3 | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | 1 |
| −2 | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| −1 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| 0 (this device) | K163326 | SmartEP | Intelligent Hearing Systems | 2017 | — |
| +1 | K193033 | GSI Audera Pro | Grason Stadler | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (2)
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 5….1820, ETN) Predicate Devices: The legally marketed devices to which equivalence is claimed: Intelligent Hearing Systems SmartEP, Model M010000 (K070608) GN Otometrics ICS Chartr EP 200 with VEMP (K143670) Device Description The SmartEP device records evoke… | 2007 |
| * | K143670 | Ics Chartr EP 200 with VempSummary page 5…lence is claimed: Intelligent Hearing Systems SmartEP, Model M010000 (K070608) GN Otometrics ICS Chartr EP 200 with VEMP (K143670) Device Description The SmartEP device records evoked potentials by using delivery of auditory, somatosensory, visual, or nerve… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193033 | GSI Audera Pro | 2020 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K193033 (Grason Stadler, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070608.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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, visual, and vestibular evoked myogenic 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…
Read the full statement (398 words)
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic 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 vestibular) 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 (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 a bone transducer or 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).
The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient’s ear (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient’s head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163326: SmartEP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163326
Report an extraction error
Are you the manufacturer?
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