FDA product code · Pathology

Media And Components, Mycoplasma Detection

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

KPBClass I21 CFR 864.2360510(k) exempt4 decisions since 19770 recalls

FDA lists KPB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1977. 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, pathology panel

Twenty years of KPB 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 · KPB

FDA has decided no KPB device since 2007.

Median 510(k) review, days · KPB

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

Recalls per year · KPB

No recall names KPB since 2007.

Adverse event reports per year · KPB

No MAUDE report names KPB 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 — KPB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KPB? 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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Other codes under 21 CFR 864.2360.

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Media And Components, Mycoplasma Detection

What has FDA decided in KPB lately?

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