510(k) · Cleared
ClearedVitek MS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Cleared on Dec 21, 2018 as substantially equivalent to DEN170081 (Bruker Daltonik GmbH, 2018) after a 205-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Dec 21, 2018
- Review
- 205 days
- Class
- Class II
- Product code
- QBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170081 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN170081 MALDI Biotyper CA SystemBruker Daltonik GmbH · 2018
- This deviceK181412 Vitek MSbioMerieux, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK212461 Vitek MS PrimebioMerieux, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK193138 Colibri SystemCopan Wasp Srl · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170081 | MALDI Biotyper CA System | Bruker Daltonik GmbH | 2018 | — |
| 0 (this device) | K181412 | Vitek MS | bioMerieux, Inc. | 2018 | — |
| +1 | K212461 | Vitek MS Prime | bioMerieux, Inc. | 2022 | — |
| +1 | K193138 | Colibri System | Copan Wasp Srl | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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
- #2 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | DEN170081 | MALDI Biotyper CA SystemSummary page 17…stantial Equivalence Information: 1. Predicate Device Name: MALDI Biotyper CA System 2. Predicate Device De Novo Submission Number: DEN170081 3. Comparison with predicate: Similarities New Device… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All QBN devicesQBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBN
1in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 54 |
| 2021 | 0 | — | 0 | 163 |
| 2022 | 1 | — | 0 | 135 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITEK® MS 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 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, yeast and mould infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181412: Vitek MS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181412
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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