FDA product code · Hematology

System, Processing For Frozen Blood

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

KSWClass II21 CFR 864.9145510(k) required1 decision since 19760 recalls

1 FDA decision since 1976. 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 KSW 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 · KSW

FDA has decided no KSW device since 2007.

Median 510(k) review, days · KSW

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

Recalls per year · KSW

No recall names KSW since 2007.

Adverse event reports per year · KSW

2in 2017

2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code KSW, 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	—	2
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KSW? 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

System, Processing For Frozen Blood

What has FDA decided in KSW lately?