510(k) · Cleared
ClearedInteracoustics Assr, Eclipse System (Cabinet Name)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jun 29, 2007 as substantially equivalent to K021895 (Bio-Logic Systems Corp., 2002) after a 108-day review. Its family tree reaches back 4 generations to 1993. 6 later devices descend from it.
- Decided
- Jun 29, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930328 (1993). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 3 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 2 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 1 generation backK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- This deviceK070696 Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007
- Descendant · cites it directly · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK220139 QScreenPath Medical GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK213345 Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero…Path Medical GmbH · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK183201 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133012SentieroPath Medical GmbH · 2014 · cites it directly4descendants
- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 2 generations on1descendant
- K220139QScreenPath Medical GmbH · 2022 · 2 generations on0descendants
- K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH · 2022 · 2 generations on0descendants
- K183201Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −3 | 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 | — |
| −1 | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| 0 (this device) | K070696 | Interacoustics Assr, Eclipse System (Cabinet Name) | Interacoustics A/S | 2007 | — |
| +1 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| +2 | K220139 | QScreen | Path Medical GmbH | 2022 | — |
| +2 | K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced… | Path Medical GmbH | 2022 | 4 |
| +3 | K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K021895 | Bio-Logic Master Evoked Response SystemSummary page 1…J SUBSTANTIAL EQUIVALENCE Precdicate Device Manufacture 510(k) No. Date Cleared Bio-logic Master Evoked Bio-logic Systems K021895 07/01/2002 Response System Corp DAIe QOa/f~tQQ7 Interacoustics ASSR - Eclip… | 2002 |
What descends from it? (6)
2 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 14 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133012 (Path Medical GmbH, 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K021895.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. The Interacoustics ASSR can be used as either simple screening device, or a diagnostic device if used as part of a group of audiometric tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants…
Read the full statement (142 words)
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions.
The Interacoustics ASSR can be used as either simple screening device, or a diagnostic device if used as part of a group of audiometric tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants, young children, cognitively impaired or uncooperative adults. It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070696 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070696: Interacoustics Assr, Eclipse System (Cabinet Name).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070696
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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