510(k) Report

FDA product code · Hematology

Fibrinogen Determination Standards And Controls

GFKClass II21 CFR 864.7340510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 GFK 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 · GFK

FDA has decided no GFK device since 2007.

Median 510(k) review, days · GFK

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

Recalls per year · GFK

No recall names GFK since 2007.

Adverse event reports per year · GFK

No MAUDE report names GFK since 2007.

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—00
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 — GFK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GFK? 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

What has FDA decided in GFK lately?

  • K823388Tens MaxFujisawa Electronics Co. · 1983

The one GFK decision →

Related product codes

Other codes under 21 CFR 864.7340.

GIL Plasma, Fibrinogen ControlGFX Fibrinogen StandardDAT Fibrinogen And Split Products, Peroxidase…DAR Fibrinogen And Split Products, Rhodamine…DAX Fibrinogen And Split Products, Fitc, Antigen…DAZ Fibrinogen And Split Products, Antigen…GIS Test, FibrinogenKQJ System, Fibrinogen Determination