510(k) · Cleared

Cleared

Amplaid A724 and A728

K992370510(k) TraditionalCleared Sep 20, 199967-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

Amplifon S.P.A. · ETY Tester, Auditory Impedance

Cleared on Sep 20, 1999 as substantially equivalent to K903066 (Amplus Corp., 1990) after a 67-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Sep 20, 1999
Review: 67 days
Class: Class II
Product code: ETY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903066 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK903066 Amplaid 770 Admittance MeterAmplus Corp. · 1990
This deviceK992370 Amplaid A724 and A728Amplifon S.P.A. · 1999
Descendant · cites it directly · 0 of its ownK031978 Amplaid A756 Screening Admittance MeterAmplaid · 2003

Most influential descendants

Showing 1 of 1 · See all

K031978Amplaid A756 Screening Admittance MeterAmplaid · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K992370, 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
*	K903066	Amplaid 770 Admittance Meter Summary page 1 …Y Common/Usual Name: Clinical Admittance Meter . Equivalent legally marketed devices This product is similar in design and function to the Amplaid 770 Admittance Meter (K903066) . Indications for Use (intended use) The Amplaid A724 — A728 are Programmable Admittance Meters which can: e Evaluate middle…	Amplus Corp.	1990	—

Also cleared against K903066: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031978	Amplaid A756 Screening Admittance Meter	Amplaid	2003	0

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.
Of its descendants, K031978 (Amplaid, 2003) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K903066.

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 A724 and A728 are Programmable Admittance Meters 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.

They are 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/K992370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992370: Amplaid A724 and A728.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992370

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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