FDA product code · Anesthesiology

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

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

NQYClass II21 CFR 868.5895510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.

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, anesthesiology panel

Twenty years of NQY 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 — NQY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NQY? 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 868.5895.

SGR Noninvasive Positive Airway Pressure System…ONZ Mechanical Ventilator MNS Ventilator, Continuous, Non-Life-Supporting MOD Accessory To Continuous Ventilator (Respirator)CBK Ventilator, Continuous, Facility Use MNT Continuous, Minimal Ventilatory Support…NOU Continuous, Ventilator, Home Use