FDA product code · Ear, nose and throat

Chamber, Acoustic (For Audiometric Testing)

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

EWCClass I21 CFR 874.1060510(k) exempt2 decisions since 19820 recalls

FDA lists EWC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1982. 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 EWC 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 · EWC

FDA has decided no EWC device since 2007.

Median 510(k) review, days · EWC

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

Recalls per year · EWC

No recall names EWC since 2007.

Adverse event reports per year · EWC

No MAUDE report names EWC since 2007.

View these four charts as a table

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

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

Planning a device in EWC? 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

Chamber, Acoustic (For Audiometric Testing)

What has FDA decided in EWC lately?