510(k) · Cleared

Cleared

Vitek MS Prime

K212461510(k) TraditionalCleared Mar 15, 2022221-day reviewClass II21 CFR 866.3378

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

bioMerieux, Inc. · QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Cleared on Mar 15, 2022 as substantially equivalent to K181412 (bioMerieux, Inc., 2018) after a 221-day review. Its family tree reaches back 2 generations to 2018.

Decided: Mar 15, 2022
Review: 221 days
Class: Class II
Product code: QBN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN170081 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN170081 MALDI Biotyper CA SystemBruker Daltonik GmbH · 2018
1 generation backK181412 Vitek MSbioMerieux, Inc. · 2018
This deviceK212461 Vitek MS PrimebioMerieux, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN170081	MALDI Biotyper CA System	Bruker Daltonik GmbH	2018	—
−1	K181412	Vitek MS	bioMerieux, Inc.	2018	—
0 (this device)	K212461	Vitek MS Prime	bioMerieux, Inc.	2022	—

FIG. 1 — Lineage of K212461, 2018–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QBN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QBN device

#1 K251495 MBT Compass HT CA Software; MBT FAST Shuttle…score 9.8 · 1 generation · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K181412	Vitek MS Summary page 9 …fication and Differentiation System Common Name: VITEK MS PRIME C. Predicate Device: VITEK® MS (K181412) Predicate:…	bioMerieux, Inc.	2018	—

Also cleared against K181412: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K181412.

How does its category compare?

All QBN devices

QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

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	—	—

What is it indicated for?

VITEK© MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens.

The VITEK© MS PRIME 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 and fungal infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212461: Vitek MS Prime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212461

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026