FDA product code · Pathology

Sera, Animal And Human

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

KISClass I21 CFR 864.2800510(k) exempt45 decisions since 19780 recalls

FDA lists KIS 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. 45 FDA decisions since 1978. 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 KIS 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 · KIS

FDA has decided no KIS device since 2007.

Median 510(k) review, days · KIS

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

Recalls per year · KIS

No recall names KIS since 2007.

Adverse event reports per year · KIS

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

Planning a device in KIS? 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

Sera, Animal And Human

What has FDA decided in KIS lately?