510(k) Report

FDA product code · Anesthesiology

Device, Heimlich Maneuver Assist

MZTClass II21 CFR 868.5115510(k) exempt1 decision0 recalls

FDA lists MZT as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. 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, anesthesiology panel

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

Planning a device in MZT? 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