510(k) Report

FDA product code · Clinical chemistry

Ferricyanide, Glucose

CGDClass II21 CFR 862.1345510(k) required0 decisions0 recalls

0 FDA decisions. 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 CGD 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 · CGD

FDA has decided no CGD device since 2007.

Median 510(k) review, days · CGD

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

Recalls per year · CGD

No recall names CGD since 2007.

Adverse event reports per year · CGD

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CGD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CGD? 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

Related product codes

Other codes under 21 CFR 862.1345.

CGA Glucose Oxidase, GlucoseLFR Glucose Dehydrogenase, GlucosePZI Prescription Use Blood Glucose Meter For…CGE Orthotoluidine, GlucoseNBW System, Test, Blood Glucose, Over The CounterMRV Drink, Glucose TolerancePYV Hospital Continuous Glucose Monitoring SystemCFR Hexokinase, GlucoseCFW Copper Reduction, Glucose