FDA product code · Ear, nose and throat

Electroglottograph

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

KLXClass II21 CFR 874.1325510(k) exempt4 decisions since 19820 recalls

FDA lists KLX 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. 4 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 KLX 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 · KLX

FDA has decided no KLX device since 2007.

Median 510(k) review, days · KLX

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

Recalls per year · KLX

No recall names KLX since 2007.

Adverse event reports per year · KLX

1in 2023

2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code KLX, 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	—	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	—	1
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KLX? 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

Electroglottograph

What has FDA decided in KLX lately?