510(k) · Cleared
ClearedMadsen Accuscreen Type 1077
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics · GWJ Stimulator, Auditory, Evoked Response
Cleared on Feb 27, 2014 as substantially equivalent to K013977 (Fischer-Zoth Audiologic Systems, Inc., 2002) and 1 other predicate after a 160-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 27, 2014
- Review
- 160 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902540 (1990). 12 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 4 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 3 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 2 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 1 generation backK122067 Type 1077 AccuscreenGn Otometrics · 2012
- This deviceK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
- Descendant · cites it directly · 2 of its ownK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK234095 OtoNova/OtoNova ProOtodynamics · 2024
- Descendant · 2 generations on · 0 of its ownK240430 Otoport ProOtodynamics, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −4 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −3 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −2 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −1 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| 0 (this device) | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
| +1 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
| +2 | K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024 | — |
| +2 | K240430 | Otoport Pro | Otodynamics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K013977 | Echo-Screen T, TA, TD, Tda, TCSummary page 1…Devices Product Name: Echo-Screen T, TA, TD, TDA, TC Type 1077 AccuScreen 510(k) Number: K013977 K122067 Classification Name: Stimulator, Auditory, Evoked… | 2002 |
| * | K122067 | Type 1077 AccuscreenSummary page 1…Echo-Screen T, TA, TD, TDA, TC Type 1077 AccuScreen 510(k) Number: K013977 K122067 Classification Name: Stimulator, Auditory, Evoked Stimulator, Auditory, Evoked _… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck… | 2015 | 2 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K143395 (Otodynamics, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K013977.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders. Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including…
Read the full statement (153 words)
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions:
The Type 1077 DPOAE module and TEOAE module 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 adults.
Auditory Brainstemn Response:
The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening.
The device is intended for use by audiologists, ENT's and other healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132957: Madsen Accuscreen Type 1077.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132957
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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