510(k) · Cleared
ClearedSmart-EP
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 Aug 2, 1991 after a 275-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Aug 2, 1991
- Review
- 275 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK904926 Smart-EPIntelligent Hearing Systems · 1991
- Descendant · cites it directly · 16 of its ownK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- Descendant · 2 generations on · 12 of its ownK123843 Neuroepg SystemStrohl Medical Technologies · 2013
- Descendant · 3 generations on · 11 of its ownK132616 EPADSafeop Surgical, Inc. · 2014
- Descendant · 4 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 5 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K070608Smartep, Model M010000Intelligent Hearing Systems · 2007 · cites it directly16descendants
- K123843Neuroepg SystemStrohl Medical Technologies · 2013 · 2 generations on12descendants
- K132616EPADSafeop Surgical, Inc. · 2014 · 3 generations on11descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 4 generations on9descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904926 | Smart-EP | Intelligent Hearing Systems | 1991 | — |
| +1 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| +2 | K123843 | Neuroepg System | Strohl Medical Technologies | 2013 | — |
| +3 | K132616 | EPAD | Safeop Surgical, Inc. | 2014 | — |
| +4 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +5 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- Of its descendants, K070608 (Intelligent Hearing Systems, 2007) has gone furthest, with 16 descendants of its own.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K904926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904926: Smart-EP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904926
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026