FDA product code · Gastroenterology and urology

Container, Transport, Kidney

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

KDKClass II21 CFR 876.5880510(k) required3 decisions since 19800 recalls

3 FDA decisions since 1980. 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, gastroenterology and urology panel

Twenty years of KDK 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 · KDK

FDA has decided no KDK device since 2007.

Median 510(k) review, days · KDK

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

Recalls per year · KDK

No recall names KDK since 2007.

Adverse event reports per year · KDK

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

Planning a device in KDK? 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 876.5880.

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Container, Transport, Kidney

What has FDA decided in KDK lately?

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