510(k) · Cleared
ClearedNavigator & Traveler Evoked Postential Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · IKN Electromyograph, Diagnostic
Cleared on Jul 2, 1993 after a 161-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 23 later devices descend from it.
- Decided
- Jul 2, 1993
- Review
- 161 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- Descendant · cites it directly · 22 of its ownK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- Descendant · 2 generations on · 21 of its ownK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- Descendant · 3 generations on · 13 of its ownK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- Descendant · 4 generations on · 6 of its ownK070696 Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007
- Descendant · 3 generations on · 5 of its ownK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K992807Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999 · cites it directly22descendants
- K994149Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999 · 2 generations on21descendants
- K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002 · 3 generations on13descendants
- K070696Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007 · 4 generations on6descendants
- K021215Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| +1 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| +2 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| +3 | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| +4 | K070696 | Interacoustics Assr, Eclipse System (Cabinet Name) | Interacoustics A/S | 2007 | — |
| +3 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 IKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992807 | Bio-Logic Evoked Potential for Abaer I | 1999 | 22 |
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, K992807 (Bio-Logic Systems Corp., 1999) has gone furthest, with 22 descendants of its own.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K930328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930328: Navigator & Traveler Evoked Postential Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930328
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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