510(k) · Cleared
ClearedEcho-Screen T, TA, TD, Tda, TC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer-Zoth Audiologic Systems, Inc. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jun 14, 2002 as substantially equivalent to K982642 (Fischer-Zoth Audiologic Systems, Inc., 1998) and 1 other predicate after a 193-day review. Its family tree reaches back 3 generations to 1990. 14 later devices descend from it.
- Decided
- Jun 14, 2002
- Review
- 193 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902540 (1990). 10 ancestors in all. 14 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 2 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 1 generation backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- This deviceK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK122067 Type 1077 AccuscreenGn Otometrics · 2012
- Descendant · cites it directly · 5 of its ownK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · 2 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
- Descendant · 2 generations on · 2 of its ownK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122067Type 1077 AccuscreenGn Otometrics · 2012 · cites it directly9descendants
- K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006 · cites it directly5descendants
- K133012SentieroPath Medical GmbH · 2014 · 2 generations on4descendants
- K132957Madsen Accuscreen Type 1077Gn Otometrics · 2014 · cites it directly3descendants
- K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −2 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −1 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| 0 (this device) | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| +1 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| +1 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +2 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +1 | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
| +2 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K982642 | Echo-ScreenSummary page 1…Name - Screening Audiometer Proprietary name - Echo-Screen T, TA, 133,TDR, TC .--. . - - - ~Devices: Predicate Fisclier-Zoth, mode1 Echo-Screen: 510(k) K982642 SIX Limited, model SABRE: 5 I O(k) K993 I77 sec also: Appendix A Ikvice dcscrbtion ,intcnded Use & Effectiveness: .I… | 1998 |
| * | K993177 | SABRE | 1999 |
| † | K931430 | Cutaneous Electrode | 1993 |
What descends from it? (14)
See all 146 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 12 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K122067 (Gn Otometrics, 2012) has gone furthest, with 9 descendants of its own.
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 Fischer-Zolh Audiologic Systems model family “Echo-Screen T“ consisting of Echo-screen T, Echo-Screen ?’A, Echo-Screen TD, Echo-Screeii TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstein Response (AHR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. ?“he device does not ineasure hearing per se, but helps to determine whether or not a hcaring loss…
Read the full statement (141 words)
The Fischer-Zolh Audiologic Systems model family “Echo-Screen T“ consisting of
Echo-screen T, Echo-Screen ?’A, Echo-Screen TD, Echo-Screeii TDA and Echo-Screen
TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstein Response
(AHR) technology.
The device is intended to screen hearing for newborns through adults, including geriatric
patients. ?“he device does not ineasure hearing per se, but helps to determine whether or
not a hcaring loss may be present.
‘The “13cho-Screen 7”’ product family consists of handheld, autoinated OAE and AM<
based heariiig screening systems which are easy to use. The measurement flow i s tticml
guidcd and the evaluation is based upon signal statistics. The “Echo-Screen T“ deviccs
are intended to be used by trained personriel in a medical or scltooi environment. ‘l‘hc
“Echo-Screen ‘T” inodeis are not intended for fitting assistive listening dcvices such as
hcaring aids or cochlcar implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013977: Echo-Screen T, TA, TD, Tda, TC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013977
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026