FDA product code · Pathology

Kit, Mycoplasma Detection

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

KIWClass I21 CFR 864.2360510(k) exempt2 decisions since 19850 recalls

FDA lists KIW 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. 2 FDA decisions since 1985. 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 KIW 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 · KIW

FDA has decided no KIW device since 2007.

Median 510(k) review, days · KIW

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

Recalls per year · KIW

No recall names KIW since 2007.

Adverse event reports per year · KIW

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

Planning a device in KIW? 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

Related product codes

Other codes under 21 CFR 864.2360.

KPB Media And Components, Mycoplasma Detection KIX Media, Mycoplasma Detection

Kit, Mycoplasma Detection

What has FDA decided in KIW lately?

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