510(k) · Cleared
ClearedEcho-Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer-Zoth Audiologic Systems, Inc. · EWO Audiometer
Cleared on Oct 21, 1998 as substantially equivalent to K974237 (Grason-Stadler, Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1990. 15 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902540 (1990). 5 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 1 generation backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- This deviceK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- Descendant · 2 generations on · 9 of its ownK122067 Type 1077 AccuscreenGn Otometrics · 2012
- Descendant · 2 generations on · 5 of its ownK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · 3 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002 · cites it directly14descendants
- K122067Type 1077 AccuscreenGn Otometrics · 2012 · 2 generations on9descendants
- K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006 · 2 generations on5descendants
- K133012SentieroPath Medical GmbH · 2014 · 3 generations on4descendants
- K132957Madsen Accuscreen Type 1077Gn Otometrics · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −1 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| 0 (this device) | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| +1 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| +2 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| +2 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +3 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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 9.4 · 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? (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 |
|---|---|---|---|
| * | K974237 | Gsi 70 Audiopath ScreenerSummary page 1…- Andiometer Common/Usual Name - Screening Audiometer Proprietary name - Echo-Screen Predicate Device: Grason Stadler Inc. model GSI70 AudioPath Screener (ref. 510(k) #K974237) and Otodynamics LTD. model ILO88 (ref. 510(k) #K962995, Device description . int E iveness: The Fischer-Zoth Audiologic System… | 1998 |
| * | K962995 | ILO88. Otodynamic Analyser, Kit System for PCSummary page 1…roprietary name - Echo-Screen Predicate Device: Grason Stadler Inc. model GSI70 AudioPath Screener (ref. 510(k) #K974237) and Otodynamics LTD. model ILO88 (ref. 510(k) #K962995, Device description . int E iveness: The Fischer-Zoth Audiologic System model “Echo-Screen’ is based upon Otoacoustic Emissions… | 1997 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013977 | Echo-Screen T, TA, TD, Tda, TC | 2002 | 14 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K013977 (Fischer-Zoth Audiologic Systems, Inc., 2002) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K974237.
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 Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and…
Read the full statement (135 words)
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient.
Otoacoustic emissions (OAEs) are low-Jeve] audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAE:s is an indication of cochlear function. If the Echo-Screen signals a “pass”™ reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.
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/K982642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982642: Echo-Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982642
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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