510(k) Report

FDA product code · Neurology

Non-Invasive Vagus Nerve Stimulator For Migraine Headache

QAKClass II21 CFR 882.5892510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache.

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, neurology panel

Twenty years of QAK 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 · QAK

FDA has decided no QAK device since 2007.

Median 510(k) review, days · QAK

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

Recalls per year · QAK

No recall names QAK since 2007.

Adverse event reports per year · QAK

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code QAK, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QAK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QAK? 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 882.5892.

PKR Non-Invasive Vagus Nerve Stimulator - Headache