FDA product code · Anesthesiology

Monitor For Opioid Induced Impairment Of Oxygenation

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

QVTClass II21 CFR 868.2250510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. No recall names this code.

A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose

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 QVT 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 · QVT

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVT

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

Recalls per year · QVT

No recall names QVT since 2007.

Adverse event reports per year · QVT

No MAUDE report names QVT since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in QVT? 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

Monitor For Opioid Induced Impairment Of Oxygenation

What has FDA decided in QVT lately?