510(k) Report

FDA product code · Microbiology

Transport Medium, Notified Per The Vtm Guidance

QMCClass I21 CFR 866.2390510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).

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 QMC 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 · QMC

FDA has decided no QMC device since 2007.

Median 510(k) review, days · QMC

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

Recalls per year · QMC

No recall names QMC since 2007.

Adverse event reports per year · QMC

1in 2023

2021: 22023: 1
2007high 2 (2021) · low 0 (2007)2025

MAUDE reports naming product code QMC, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—02
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — QMC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QMC? 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 866.2390.