510(k) Report

FDA product code · Ear, nose and throat

Device, Voice Amplification

MCKClass II21 CFR 874.3730510(k) exempt0 decisions0 recalls

FDA lists MCK 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. 0 FDA decisions. 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 MCK 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 · MCK

FDA has decided no MCK device since 2007.

Median 510(k) review, days · MCK

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

Recalls per year · MCK

No recall names MCK since 2007.

Adverse event reports per year · MCK

2in 2009

2007: 12009: 2
2007high 2 (2009) · low 0 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—02
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MCK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MCK? 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

Related product codes

Other codes under 21 CFR 874.3730.

EWL Prosthesis, Laryngeal (Taub)