FDA product code · Hematology

Device, Automated Sedimentation Rate

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

GKBClass I21 CFR 864.5800510(k) exempt2 decisions since 19890 recalls

FDA lists GKB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1989. 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 GKB 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 · GKB

FDA has decided no GKB device since 2007.

Median 510(k) review, days · GKB

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

Recalls per year · GKB

No recall names GKB since 2007.

Adverse event reports per year · GKB

1in 2024

2007high 2 (2018) · low 0 (2007)2025

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

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	—	2
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

FIG. 1 — GKB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GKB? 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

Device, Automated Sedimentation Rate

What has FDA decided in GKB lately?