510(k) Report

FDA product code · Hematology

Reagent, Thromboplastin And Control

GGOClass II21 CFR 864.7925510(k) required1 decision since 20010 recalls

1 FDA decision since 2001. 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 GGO 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 · GGO

FDA has decided no GGO device since 2007.

Median 510(k) review, days · GGO

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

Recalls per year · GGO

No recall names GGO since 2007.

Adverse event reports per year · GGO

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

Planning a device in GGO? 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 GGO lately?

  • K010158Thrombomax-HS with Calcium, Model T6540Sigma Diagnostics, Inc. · 2001

The one GGO decision →

Related product codes

Other codes under 21 CFR 864.7925.

GFO Activated Partial ThromboplastinGIT Reagent & Control, Partial Thromboplastin TimeGGW Test, Time, Partial Thromboplastin