510(k) · Cleared
ClearedGsi SA60 Dpoae System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grason-Stadler, Inc. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on Jun 6, 1997 as substantially equivalent to K934658 (Lucas Grason-Stadler, Inc., 1994) after a 130-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 6, 1997
- Review
- 130 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934658 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934658 Gsi 60 Dpoae SystemLucas Grason-Stadler, Inc. · 1994
- This deviceK970324 Gsi SA60 Dpoae SystemGrason-Stadler, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934658 | Gsi 60 Dpoae System | Lucas Grason-Stadler, Inc. | 1994 | — |
| 0 (this device) | K970324 | Gsi SA60 Dpoae System | Grason-Stadler, Inc. | 1997 | — |
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 ETW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K934658 | Gsi 60 Dpoae SystemSummary page 1…ame - Otoacoustic Emissions/Screening Audiometer Proprietary Name - GSI SA60 DPOAE System Predicate Device: Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1). Device Description, intended Use & Effectiveness: The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Au… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K934658.
How does its category compare?
All ETW devicesETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETW
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ETW
Too few ETW 510(k)s in any year since 2007 to give a median.
Recalls per year · ETW
No recall names ETW since 2007.
Adverse event reports per year · ETW
1in 2025
MAUDE reports naming product code ETW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the stdtus of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion…
Read the full statement (111 words)
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the stdtus of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GS! 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.
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/K970324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970324: Gsi SA60 Dpoae System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970324
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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