FDA product code · Neurology

Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

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

QYNClass I21 CFR 890.5775510(k) exempt1 decision0 recalls

FDA lists QYN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. No recall names this code.

An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies

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 QYN 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.

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

Planning a device in QYN? 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