510(k) · Cleared
ClearedAmplaid AM50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplifon S.P.A. · ETY Tester, Auditory Impedance
Cleared on Feb 10, 1998 as substantially equivalent to K802097 (Amplaid USA, Inc., 1980) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Feb 10, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802097 (1980). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802097 Self-Recording Admittance Meter 709Amplaid USA, Inc. · 1980
- This deviceK974235 Amplaid AM50Amplifon S.P.A. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802097 | Self-Recording Admittance Meter 709 | Amplaid USA, Inc. | 1980 | — |
| 0 (this device) | K974235 | Amplaid AM50 | Amplifon S.P.A. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K802097 | Self-Recording Admittance Meter 709Summary page 1…Common/Usual Name: Clinical Admittance Meter . Equivalent legally marketed devices This product is similar in design and function to the Amplaid 709 Admittance Meter (K802097) and the 770 Admittance Meter (K903066) . Indications for Use (intended use) The Amplaid AMS50 is a Programmable Admittance Met… | 1980 |
| * | K903066 | Amplaid 770 Admittance MeterSummary page 1…Meter . Equivalent legally marketed devices This product is similar in design and function to the Amplaid 709 Admittance Meter (K802097) and the 770 Admittance Meter (K903066) . Indications for Use (intended use) The Amplaid AMS50 is a Programmable Admittance Meter which can: ¢ Evaluate middle ear fu… | 1990 |
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?
- None of the 2 ancestors has a 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 Amplaid AMS50 is a Programmable Admittance Meter which can
1. Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
2. Perform Acoustic reflex test.
3. Determine acoustic reflex threshold
4. Perform reflex decay test.
It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
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/K974235 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974235: Amplaid AM50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974235
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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