FDA product code · Gastroenterology and urology

Recorder, External, Pressure, Amplifier & Transducer

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

FESClass II21 CFR 876.1725510(k) required2 decisions since 19800 recalls

2 FDA decisions 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, gastroenterology and urology panel

Twenty years of FES 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 · FES

FDA has decided no FES device since 2007.

Median 510(k) review, days · FES

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

Recalls per year · FES

No recall names FES since 2007.

Adverse event reports per year · FES

No MAUDE report names FES 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 — FES by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FES? 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

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Recorder, External, Pressure, Amplifier & Transducer

What has FDA decided in FES lately?

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