FDA product code · Anesthesiology

Implanted Diaphragmatic/Phrenic Nerve Stimulator

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

GZEClass III21 CFR 882.5830PMA required1 decision since 19870 recalls

1 FDA decision since 1987. No recall names this code.

Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86

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 GZE 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 · GZE

1in 2019

2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZE

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

Recalls per year · GZE

No recall names GZE since 2007.

Adverse event reports per year · GZE

1in 2023

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code GZE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	1
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	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in GZE? 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

Implanted Diaphragmatic/Phrenic Nerve Stimulator

What has FDA decided in GZE lately?