FDA product code · Ear, nose and throat

Hearing Aid, Master

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

KHLClass II21 CFR 874.3330510(k) exempt7 decisions since 19790 recalls

FDA lists KHL 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. 7 FDA decisions since 1979. 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 KHL 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 · KHL

FDA has decided no KHL device since 2007.

Median 510(k) review, days · KHL

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

Recalls per year · KHL

No recall names KHL since 2007.

Adverse event reports per year · KHL

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

Planning a device in KHL? 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

Hearing Aid, Master

What has FDA decided in KHL lately?