FDA product code · Hematology

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

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

KSNClass II21 CFR 864.9285510(k) required1 decision since 19790 recalls

1 FDA decision since 1979. 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 KSN 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 · KSN

FDA has decided no KSN device since 2007.

Median 510(k) review, days · KSN

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

Recalls per year · KSN

No recall names KSN since 2007.

Adverse event reports per year · KSN

1in 2012

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code KSN, 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	—	1
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 — KSN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KSN? 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

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

What has FDA decided in KSN lately?