510(k) · Cleared
ClearedVitek MS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Cleared on Jul 22, 2017 as substantially equivalent to DEN130013 (bioMerieux, Inc., 2013) and 1 other predicate after a 271-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Jul 22, 2017
- Review
- 271 days
- Class
- Class II
- Product code
- PEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN130013 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130013 Vitek MSbioMerieux, Inc. · 2013
- This deviceK162950 Vitek MSbioMerieux, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130013 | Vitek MS | bioMerieux, Inc. | 2013 | — |
| 0 (this device) | K162950 | Vitek MS | bioMerieux, Inc. | 2017 | — |
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 PEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN130013 | Vitek MSSummary page 9…® Common Name: VITEK MS, VITEK MS C. Predicate Device: VITEK® MS (DEN130013 / K124067) D. 510(k) Summary: VITEK® MS is mass spectrometry system using matrix-assisted laser desorption/ionization–t… | 2013 |
| * | DEN130013 | Vitek MS Our reading of the summary gave K124067, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130013, Vitek MS (bioMerieux, Inc.), granted Aug 21, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN130013.
How does its category compare?
All PEX devicesPEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PEX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PEX
Too few PEX 510(k)s in any year since 2007 to give a median.
Recalls per year · PEX
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEX
4in 2021
MAUDE reports naming product code PEX, 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 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 2 | — | 0 | 94 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 107 |
| 2020 | 0 | — | 0 | 89 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162950 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162950: Vitek MS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162950
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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