FDA product code · Microbiology

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

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

QQVClass II21 CFR 866.3378510(k) required4 decisions since 20210 recalls

4 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 574 days (half between 317 and 790). No recall names this code. The most-cited predicate is K223245, named by 1 later device.

An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).

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 QQV 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 · QQV

2in 2023

2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QQV

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

Recalls per year · QQV

No recall names QQV since 2007.

Adverse event reports per year · QQV

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code QQV, 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	0	—	0
2019	0	—	0
2020	0	—	0
2021	2	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

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

Planning a device in QQV? 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…QBN Mass Spectrometry, Maldi Tof, Microorganism…

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Which predicates do QQV devices cite most?

Which QQV devices have the deepest lineage?

What has FDA decided in QQV lately?

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