510(k) · Cleared
ClearedAmerican Electromedics Race Car Tympanometer W/Integral Printer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Electromedics Corp. · ETY Tester, Auditory Impedance
Cleared on Nov 17, 1998 as substantially equivalent to K955289 (American Electromedics Corp., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 17, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955289 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK955289 Race Car TympanometerAmerican Electromedics Corp. · 1995
- This deviceK983046 American Electromedics Race Car Tympanometer W/Integral PrinterAmerican Electromedics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955289 | Race Car Tympanometer | American Electromedics Corp. | 1995 | — |
| 0 (this device) | K983046 | American Electromedics Race Car Tympanometer W/Integral Printer | American Electromedics Corp. | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K955289 | Race Car TympanometerSummary page 1…tromedics Race Car Tympanometer With Integral Printer Classification Number: 77ETY Substantial Equivalence: Race Car Tympanometer, American Electromedics Corporation (K955289) Device Description: The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer. Inten… | 1995 |
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.
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 | — |
What is it indicated for?
The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
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/K983046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983046: American Electromedics Race Car Tympanometer W/Integral Printer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983046
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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