FDA product code · Anesthesiology

Gas, Collecting Vessel

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

KGKClass I21 CFR 868.1575510(k) exempt2 decisions since 19770 recalls

FDA lists KGK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 2 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, anesthesiology panel

Twenty years of KGK 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 · KGK

FDA has decided no KGK device since 2007.

Median 510(k) review, days · KGK

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

Recalls per year · KGK

No recall names KGK since 2007.

Adverse event reports per year · KGK

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

Planning a device in KGK? 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

Gas, Collecting Vessel

What has FDA decided in KGK lately?