FDA product code · Microbiology

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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

QBNClass II21 CFR 866.3378510(k) required4 decisions since 20180 recalls

4 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 156 days (half between 123 and 188). No recall names this code. The most-cited predicate is DEN170081, named by 3 later devices.

The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial…

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 QBN 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 · QBN

1in 2025

2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QBN

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

Recalls per year · QBN

No recall names QBN since 2007.

Adverse event reports per year · QBN

2in 2025

2007high 163 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	2	—	0
2019	0	—	0
2020	0	—	54
2021	0	—	163
2022	1	—	135
2023	0	—	39
2024	0	—	17
2025	1	—	2
2026	0	—	—

FIG. 1 — QBN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QBN? 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 866.3378.

QNJ Mass Spectrometry, Microorganism…QQV Automated System For Sample Preparation And…

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

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