510(k) Report

FDA product code · Hematology

Thrombin

GJBClass II21 CFR 864.7875510(k) required1 decision since 19820 recalls

1 FDA decision since 1982. 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 GJB 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 · GJB

FDA has decided no GJB device since 2007.

Median 510(k) review, days · GJB

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

Recalls per year · GJB

No recall names GJB since 2007.

Adverse event reports per year · GJB

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

Planning a device in GJB? 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 GJB lately?

  • K820084Clotting Time ReagentAmerican Dade · 1982

The one GJB decision →

Related product codes

Other codes under 21 CFR 864.7875.

GJA Test, Thrombin Time