FDA product code · Hematology

Cyanomethemoglobin

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

GKKClass II21 CFR 864.7500510(k) required7 decisions since 19770 recalls

7 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, hematology panel

Twenty years of GKK 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 · GKK

FDA has decided no GKK device since 2007.

Median 510(k) review, days · GKK

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

Recalls per year · GKK

No recall names GKK since 2007.

Adverse event reports per year · GKK

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

Planning a device in GKK? 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 864.7500.

KHG Whole Blood Hemoglobin Determination LGL Assay, Bart'S, Hemoglobin GJZ Cyanomethemoglobin Reagent And Standard Solution GIG Hemoglobinometer GGF Acid Hematin GGZ Oxyhemoglobin GLY Oximeter To Measure Hemoglobin QGU Hemoglobin For Donor Testing

Cyanomethemoglobin

What has FDA decided in GKK lately?

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