510(k) · Cleared
ClearedModification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Dec 27, 1999 as substantially equivalent to K992807 (Bio-Logic Systems Corp., 1999) after a 19-day review. Its family tree reaches back 2 generations to 1993. 21 later devices descend from it.
- Decided
- Dec 27, 1999
- Review
- 19 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930328 (1993). 21 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 1 generation backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- This deviceK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- Descendant · cites it directly · 13 of its ownK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- Descendant · 2 generations on · 6 of its ownK070696 Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007
- Descendant · cites it directly · 5 of its ownK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
- Descendant · 3 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002 · cites it directly13descendants
- K070696Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007 · 2 generations on6descendants
- K021215Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002 · cites it directly5descendants
- K133012SentieroPath Medical GmbH · 2014 · 3 generations on4descendants
- K021801Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| +1 | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| +2 | K070696 | Interacoustics Assr, Eclipse System (Cabinet Name) | Interacoustics A/S | 2007 | — |
| +1 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
| +3 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (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 |
|---|---|---|---|
| * | K992807 | Bio-Logic Evoked Potential for Abaer ISummary page 1…sponse System. CLASSIFICATION NAME: Evoked Response Auditory Stimulator (per CFR 882-1900). PREDICATE DEVICE: Bio-logic Evoked Potential for ABAER 1, reference 510(k) #K992807. DESCRIPTION OF THE DEVICE: The Bio-logic Evoked Potential family of products is intended to be used for the recording and anal… | 1999 |
| † | K803226 | Evoked Response Stimulators | 1981 |
| † | K842543 | Evoked Potential Sys | 1984 |
| † | K844992 | Bio-Logic Portable Evoked Response System | 1985 |
| † | K862690 | Traveler LT | 1986 |
| † | K930328 | Navigator & Traveler Evoked Postential Product | 1993 |
What descends from it? (21)
See all 214 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 6 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021895 (Bio-Logic Systems Corp., 2002) has gone furthest, with 13 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 | — |
What is it indicated for?
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented to the patient’s ear through an earphone or headphones, and the Brainstem Auditory Evoked Response from the patient is recorded using EEG electrodes placed on the scalp. Although this Brainstem Response…
Read the full statement (369 words)
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological
data necessary for the diagnosis of auditory and hearing-related disorders. An auditory stimulus (click, tone, etc.) is presented
to the patient’s ear through an earphone or headphones, and the Brainstem Auditory Evoked Response from the patient is
recorded using EEG electrodes placed on the scalp. Although this Brainstem Response is very low in amplitude (with respect
to surrounding EEG “noise™), the stimulus-response cycle is repeated many times and the resulting responses are averaged from
the time of the stimuli. The random noise averages to zero, but if the Brainstem Response signal is present, it’s signal will be
easily determined in the averaged signal.
The Bio-logic EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It
is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as
infants, young children, and cognitively impaired or uncooperative adults. The use of the Bio-logic EP family of products is to
be performed under the prescription and supervision of a physician or other trained health care professional.
The feature modifications represented in this Special 510(k) are for the use of a redesigned hardware package and a Windows-
based software program to control the hardware. The functions and electronic design of the hardware are substantially the same
as those of the Predicate Device hardware. The software for control of this device is a simplified subset of the DOS-based
Predicate Device software. Together, they implement the same infant hearing screening functions and perform the same
intended use as the Predicate Device, but with improved ease-of-use. The POVR algorithm described in the Predicate Device is
implemented in the new Windows software to generally assist in test data interpretation, and specifically assist in the assessment
of signal-to-noise ratio and the quality of the Brainstem Auditory Evoked Response in infants. Based on this automatic
assessment, the speed of testing may be reduced and/or the quality of the data recording may be improved, without
compromising the quality of recorded data or limiting the control and flexibility of the health care professional administering
the test.
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/K994149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994149
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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