510(k) · Cleared

Cleared

Amplaid A756 Screening Admittance Meter

K031978510(k) SpecialCleared Jul 21, 200325-day reviewClass II21 CFR 874.1090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Amplaid · ETY Tester, Auditory Impedance

Cleared on Jul 21, 2003 as substantially equivalent to K992370 (Amplifon S.P.A., 1999) after a 25-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jul 21, 2003
Review: 25 days
Class: Class II
Product code: ETY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K903066 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK903066 Amplaid 770 Admittance MeterAmplus Corp. · 1990
1 generation backK992370 Amplaid A724 and A728Amplifon S.P.A. · 1999
This deviceK031978 Amplaid A756 Screening Admittance MeterAmplaid · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903066	Amplaid 770 Admittance Meter	Amplus Corp.	1990	—
−1	K992370	Amplaid A724 and A728	Amplifon S.P.A.	1999	—
0 (this device)	K031978	Amplaid A756 Screening Admittance Meter	Amplaid	2003	—

FIG. 1 — Lineage of K031978, 1990–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K992370	Amplaid A724 and A728 Summary page 1 …on/Usual Name: Admittance Meter 2. Equivalent legally marketed devices This product is similar in design and function to the AMPLAID A724 and A728 ADMITTANCE METERS (K992370) 3. Indications for Use (intended use) The Amplaid A756 Screening Admittance Meter can 0 Evaluate middle ear functions such as…	Amplifon S.P.A.	1999	—

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?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All ETY devices

ETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETY

1in 2019

2007high 2 (2015) · low 0 (2010)2026

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

2007high 1 (2011) · low 0 (2007)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	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	1
2012	1	—	0
2013	0	—	1
2014	1	—	0
2015	2	—	0
2016	2	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Amplaid A756 Screening Admittance Meter 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.

The unit is intended for use by a qualifiedtrained audiologist on both adult and pediatric subjects

for measurement of acoustic impedance.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031978 · printed Nov 3, 2026

Cite this page

510(k) Report. “K031978: Amplaid A756 Screening Admittance Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031978

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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