510(k) Report

FDA product code · Microbiology

Microbial Nucleic Acid Storage And Stabilization Device

QBDClass II21 CFR 866.2950510(k) required17 decisions since 20182 recalls

17 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 330 days (half between 228 and 422). 2 recalls name this code, 2 of them Class I. The most-cited predicate is K202641, named by 6 later devices.

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

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 QBD 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 · QBD

1in 2025

2018: 12020: 22021: 12022: 22023: 52024: 52025: 1
2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QBD

651in 2024

2023: 286 days median2024: 651 days median
2007high 651 (2024) · low 286 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QBD

2in 2022

2022: 2, 2 Class I
2007high 2 (2022) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · QBD

No MAUDE report names QBD since 2007.

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
20181—00
20190—00
20202—00
20211—00
20222—2 (2)0
2023528600
2024565100
20251—00
20260—0—
FIG. 1 — QBD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QBD? 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