510(k) · Cleared
ClearedBio-Logic Master Evoked Response System
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 Jul 1, 2002 as substantially equivalent to K994149 (Bio-Logic Systems Corp., 1999) after a 21-day review. Its family tree reaches back 3 generations to 1993. 13 later devices descend from it.
- Decided
- Jul 1, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930328 (1993). 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 2 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 1 generation backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- This deviceK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- Descendant · cites it directly · 6 of its ownK070696 Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007
- Descendant · 2 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK031051 Smartep-Assr, Model M811007Intelligent Hearing Systems · 2004
- Descendant · 3 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK073626 Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp. · 2008
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K070696Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007 · cites it directly6descendants
- K133012SentieroPath Medical GmbH · 2014 · 2 generations on4descendants
- K031051Smartep-Assr, Model M811007Intelligent Hearing Systems · 2004 · cites it directly3descendants
- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 3 generations on1descendant
- K073626Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −2 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −1 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| 0 (this device) | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| +1 | K070696 | Interacoustics Assr, Eclipse System (Cabinet Name) | Interacoustics A/S | 2007 | — |
| +2 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +1 | K031051 | Smartep-Assr, Model M811007 | Intelligent Hearing Systems | 2004 | — |
| +3 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| +1 | K073626 | Bio-Logic Master II Evoked Response System | Bio-Logic Systems Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Summary page 1…SIFICATION NAME: Evoked Response Auditory Stimulator (per CFR 882- 1900). PREDICATE DEVICE: Navigator Pro Evoked Potential device, reference 5 I O(k) K 9 9 4 149. DESCRIPTION OF THE DEVICE: The Bio-logic Evoked Potential family of products is intended to be used for the recording and anal… | 1999 |
What descends from it? (13)
See all 133 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 9 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070696 (Interacoustics A/S, 2007) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K994149.
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. This product, MASTER, like its predicate device, the Navigator Fro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in testing individuals for whom behavioral audiometric results…
Read the full statement (208 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.
This product, MASTER, like its predicate device, the Navigator Fro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. 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. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-state Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.
Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021895: Bio-Logic Master Evoked Response System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021895
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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