FDA product code · General hospital

Cream, Gloving, Surgeon'S

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

KGQClass I21 CFR 878.4470510(k) exempt1 decision since 19910 recalls

FDA lists KGQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1991. 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, general hospital panel

Twenty years of KGQ 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 · KGQ

FDA has decided no KGQ device since 2007.

Median 510(k) review, days · KGQ

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

Recalls per year · KGQ

No recall names KGQ since 2007.

Adverse event reports per year · KGQ

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

Planning a device in KGQ? 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

Cream, Gloving, Surgeon'S

What has FDA decided in KGQ lately?