FDA product code · Hematology

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

KSRClass II21 CFR 864.9100510(k) required16 decisions since 19774 recalls

16 FDA decisions since 1977. 4 recalls name this code, 0 of them Class I.

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 KSR 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 · KSR

FDA has decided no KSR device since 2007.

Median 510(k) review, days · KSR

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

Recalls per year · KSR

2in 2012

2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KSR

10in 2025

2007high 82 (2009) · low 3 (2018)2025

MAUDE reports naming product code KSR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	46
2008	—	0	47
2009	—	0	82
2010	—	0	39
2011	—	0	11
2012	—	2	41
2013	—	0	71
2014	—	0	11
2015	—	0	8
2016	—	0	5
2017	—	0	4
2018	—	0	3
2019	—	0	9
2020	—	0	21
2021	—	0	17
2022	—	0	11
2023	—	0	20
2024	—	0	25
2025	—	0	10
2026	—	0	—

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

Planning a device in KSR? 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 KSR lately?

What has been recalled in KSR lately?