510(k) · Cleared
ClearedGsi 70 Audiopath Screener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grason-Stadler, Inc. · EWO Audiometer
Cleared on Feb 10, 1998 as substantially equivalent to K934658 (Lucas Grason-Stadler, Inc., 1994) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1990. 18 later devices descend from it.
- Decided
- Feb 10, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902540 (1990). 3 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- This deviceK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- Descendant · cites it directly · 15 of its ownK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- Descendant · 2 generations on · 14 of its ownK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- Descendant · 3 generations on · 9 of its ownK122067 Type 1077 AccuscreenGn Otometrics · 2012
- Descendant · 3 generations on · 5 of its ownK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · 4 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K982642Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998 · cites it directly15descendants
- K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002 · 2 generations on14descendants
- K122067Type 1077 AccuscreenGn Otometrics · 2012 · 3 generations on9descendants
- K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006 · 3 generations on5descendants
- K133012SentieroPath Medical GmbH · 2014 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| 0 (this device) | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| +1 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| +2 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| +3 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| +3 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +4 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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 EWO? 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 EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K934658 | Gsi 60 Dpoae SystemSummary page 1…er Common/Usual Name - Screening Audiometer Proprietary Name - GSI 70 AudioPath™ Screener Predicate Device: Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and the GSI 17 Screening Audiometer (ref. 510(k) #K902540 ).. Nevice Descorintsn, N… | 1994 |
| * | K911095 | Gsi 37 Auto TympSummary page 1…er Proprietary Name - GSI 70 AudioPath™ Screener Predicate Device: Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and the GSI 17 Screening Audiometer (ref. 510(k) #K902540 ).. Nevice Descorintsn, Nendad Usz & Effactivenases: The Grason-St… | 1991 |
| * | K902540 | Gsi 17 Screening AudiometerSummary page 1…evice: Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and the GSI 17 Screening Audiometer (ref. 510(k) #K902540 ).. Nevice Descorintsn, Nendad Usz & Effactivenases: The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and… | 1990 |
What descends from it? (18)
See all 182 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?
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has…
Read the full statement (141 words)
The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.
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/K974237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974237: Gsi 70 Audiopath Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974237
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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