FDA product code · Microbiology

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

KZBClass I21 CFR 866.2170510(k) exempt1 decision since 19890 recalls

FDA lists KZB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1989. 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, microbiology panel

Twenty years of KZB 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 · KZB

FDA has decided no KZB device since 2007.

Median 510(k) review, days · KZB

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

Recalls per year · KZB

No recall names KZB since 2007.

Adverse event reports per year · KZB

1in 2010

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code KZB, 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	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	0
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 — KZB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KZB? 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

Automated Colony Counter

What has FDA decided in KZB lately?