FDA product code · Ear, nose and throat

Apparatus, Visual Reinforcement Audiometric

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

LYNClass II21 CFR 874.1050510(k) exempt3 decisions since 19890 recalls

FDA lists LYN 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. 3 FDA decisions since 1989. 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 LYN 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 · LYN

FDA has decided no LYN device since 2007.

Median 510(k) review, days · LYN

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

Recalls per year · LYN

No recall names LYN since 2007.

Adverse event reports per year · LYN

No MAUDE report names LYN 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 — LYN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LYN? 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

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Apparatus, Visual Reinforcement Audiometric

What has FDA decided in LYN lately?

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