510(k) · Cleared
ClearedAmerican Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer with Integral Printer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Electromedics Corp. · EWO Audiometer
Cleared on Nov 17, 1998 as substantially equivalent to K970279 (American Electromedics Corp., 1997) after a 77-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Nov 17, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970279 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970279 Race Car Tympanometer with Audiometer (AE-Rcaud I/Quik Tymp…American Electromedics Corp. · 1997
- This deviceK983048 American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer…American Electromedics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970279 | Race Car Tympanometer with Audiometer (AE-Rcaud I/Quik Tymp 1(AE-Quik 1)/Quick… | American Electromedics Corp. | 1997 | — |
| 0 (this device) | K983048 | American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer with Integral… | 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 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 9.3 · 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? (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 |
|---|---|---|---|
| * | K970279 | Race Car Tympanometer with Audiometer (AE-Rcaud I/Quik Tymp 1(AE-Quik 1)/Quick Tymp…Summary page 1…lassification Number: 77ETY and 77EWO Substantial Equivalence: Race Car Tympanometer With Audiometer and Quik Tymp2, and Quik Tympl, American Electromedics Corporation (K970279) Device Description: The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination… | 1997 |
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 K970279.
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 American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer 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/K983048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983048: American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer with 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/K983048
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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