FDA product code · Hematology

Red-Cell Indices

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

KQHClass II21 CFR 864.5300510(k) required1 decision since 19860 recalls

1 FDA decision since 1986. 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 KQH 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 · KQH

FDA has decided no KQH device since 2007.

Median 510(k) review, days · KQH

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

Recalls per year · KQH

No recall names KQH since 2007.

Adverse event reports per year · KQH

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

Planning a device in KQH? 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 864.5300.

JBW Red-Cell Indices, Measured JPJ Red-Cell Indices, Calculated

Red-Cell Indices

What has FDA decided in KQH lately?

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