FDA product code · Hematology

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

KSEClass II21 CFR 864.9700510(k) exempt4 decisions since 19800 recalls

FDA lists KSE 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. 4 FDA decisions since 1980. 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 KSE 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 · KSE

FDA has decided no KSE device since 2007.

Median 510(k) review, days · KSE

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

Recalls per year · KSE

No recall names KSE since 2007.

Adverse event reports per year · KSE

2in 2020

2007high 32 (2008) · low 0 (2011)2025

MAUDE reports naming product code KSE, 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	—	1
2008	—	32
2009	—	1
2010	—	2
2011	—	0
2012	—	1
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	3
2020	—	2
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KSE? 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

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What has FDA decided in KSE lately?