510(k) · Cleared
ClearedGsi 2000 Middle Ear Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grason-Stadler, Inc. · ETY Tester, Auditory Impedance
Cleared on Apr 12, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 12, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK000097 Gsi 2000 Middle Ear AnalyzerGrason-Stadler, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK033645 Otoflex 100 Tye 1012Gn Otometrics A/S · 2004
- Descendant · 2 generations on · 1 of its ownK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
- Descendant · 2 generations on · 0 of its ownK161707 Madsen ZodiacGn Otometrics · 2016
- Descendant · cites it directly · 0 of its ownK112733 ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
Most influential descendants
Showing 5 of 5 · See all- K033645Otoflex 100 Tye 1012Gn Otometrics A/S · 2004 · cites it directly3descendants
- K061104Speechlink 100 Type 1053Gn Otometrics A/S · 2006 · 2 generations on1descendant
- K161707Madsen ZodiacGn Otometrics · 2016 · 2 generations on0descendants
- K112733ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011 · cites it directly0descendants
- K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000097 | Gsi 2000 Middle Ear Analyzer | Grason-Stadler, Inc. | 2000 | — |
| +1 | K033645 | Otoflex 100 Tye 1012 | Gn Otometrics A/S | 2004 | — |
| +2 | K061104 | Speechlink 100 Type 1053 | Gn Otometrics A/S | 2006 | — |
| +2 | K161707 | Madsen Zodiac | Gn Otometrics | 2016 | — |
| +1 | K112733 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2011 | — |
| +3 | K110286 | GN Otometrics Type 1053 Freefit | Gn Otometrics A/S | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETY? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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?
- Of its descendants, K033645 (Gn Otometrics A/S, 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETY
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ETY
Too few ETY 510(k)s in any year since 2007 to give a median.
Recalls per year · ETY
No recall names ETY since 2007.
Adverse event reports per year · ETY
1in 2025
MAUDE reports naming product code ETY, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000097: Gsi 2000 Middle Ear Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000097
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026