510(k) Report

FDA product code · Microbiology

Dna-Probe, Agent, Listeria

MCGClass I21 CFR 866.3355510(k) exempt0 decisions0 recalls

FDA lists MCG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 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, microbiology panel

Twenty years of MCG 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 · MCG

FDA has decided no MCG device since 2007.

Median 510(k) review, days · MCG

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

Recalls per year · MCG

No recall names MCG since 2007.

Adverse event reports per year · MCG

1in 2025

2008: 12010: 22015: 12025: 1
2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code MCG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20100—02
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — MCG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MCG? 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 866.3355.

GSG Antisera, Fluorescent, All Types, Listeria…GSI Antigens, Slide And Tube, All Types, Listeria…GSH Antisera, All Types, Listeria Monocytogenes