FDA product code · Microbiology

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

KZKClass I21 CFR 866.2850510(k) required3 decisions since 19940 recalls

3 FDA decisions since 1994. 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 KZK 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 · KZK

FDA has decided no KZK device since 2007.

Median 510(k) review, days · KZK

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

Recalls per year · KZK

No recall names KZK since 2007.

Adverse event reports per year · KZK

No MAUDE report names KZK since 2007.

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	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KZK? 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 KZK lately?