FDA product code · Anesthesiology

Monitor, Lung Water Measurement

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

JEZClass III21 CFR 868.2450PMA required1 decision since 19800 recalls

1 FDA decision since 1980. 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 JEZ 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 · JEZ

FDA has decided no JEZ device since 2007.

Median 510(k) review, days · JEZ

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

Recalls per year · JEZ

No recall names JEZ since 2007.

Adverse event reports per year · JEZ

No MAUDE report names JEZ since 2007.

View these four charts as a table

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

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

Planning a device in JEZ? 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, Lung Water Measurement

What has FDA decided in JEZ lately?