FDA product code · Hematology

Assay, Bart'S, Hemoglobin

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

LGLClass II21 CFR 864.7500510(k) required2 decisions since 19810 recalls

2 FDA decisions since 1981. 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 LGL 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 · LGL

FDA has decided no LGL device since 2007.

Median 510(k) review, days · LGL

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

Recalls per year · LGL

No recall names LGL since 2007.

Adverse event reports per year · LGL

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

Planning a device in LGL? 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.

GKK Cyanomethemoglobin KHG Whole Blood Hemoglobin Determination GJZ Cyanomethemoglobin Reagent And Standard Solution GIG Hemoglobinometer GGF Acid Hematin GGZ Oxyhemoglobin GLY Oximeter To Measure Hemoglobin QGU Hemoglobin For Donor Testing

Assay, Bart'S, Hemoglobin

What has FDA decided in LGL lately?

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