FDA product code · Hematology

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

KSIClass II21 CFR 864.9550510(k) exempt4 decisions since 19800 recalls

FDA lists KSI 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 KSI 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 · KSI

FDA has decided no KSI device since 2007.

Median 510(k) review, days · KSI

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

Recalls per year · KSI

No recall names KSI since 2007.

Adverse event reports per year · KSI

700in 2025

2007high 700 (2025) · low 0 (2007)2025

MAUDE reports naming product code KSI, 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	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	700
2026	—	—

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

Planning a device in KSI? 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 KSI lately?