FDA product code · Ear, nose and throat

Protector, Hearing (Circumaural)

Name: FDA decisions, review times, recalls and adverse event reports for product code EWE
Creator: 510(k) Report

EWEClass U1 decision since 19950 recalls

1 FDA decision since 1995. No recall names this code.

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

FIG. A — Illustration, ear, nose and throat panel

Twenty years of EWE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · EWE

FDA has decided no EWE device since 2007.

Median 510(k) review, days · EWE

Too few EWE 510(k)s in any year since 2007 to give a median.

Recalls per year · EWE

No recall names EWE since 2007.

Adverse event reports per year · EWE

2in 2019

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code EWE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — EWE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EWE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Protector, Hearing (Circumaural)

Which EWE devices have the deepest lineage?

What has FDA decided in EWE lately?