FDA product code · Clinical chemistry

Orthotoluidine, Glucose

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

CGEClass II21 CFR 862.1345510(k) required12 decisions since 19770 recalls

12 FDA decisions since 1977. 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, clinical chemistry panel

Twenty years of CGE 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 · CGE

FDA has decided no CGE device since 2007.

Median 510(k) review, days · CGE

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

Recalls per year · CGE

No recall names CGE since 2007.

Adverse event reports per year · CGE

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

Planning a device in CGE? 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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Other codes under 21 CFR 862.1345.

CGA Glucose Oxidase, Glucose LFR Glucose Dehydrogenase, Glucose PZI Prescription Use Blood Glucose Meter For…CGD Ferricyanide, Glucose NBW System, Test, Blood Glucose, Over The Counter MRV Drink, Glucose Tolerance PYV Hospital Continuous Glucose Monitoring System CFR Hexokinase, Glucose CFW Copper Reduction, Glucose

Orthotoluidine, Glucose

What has FDA decided in CGE lately?

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