De Novo · Granted
GrantedVitek 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
Granted on Aug 21, 2013 as a new device type through De Novo after a 231-day review. 4 later devices descend from it.
- Decided
- Aug 21, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- PEX
- Recalls
- None
4 later devices descend from it, 3 citing it directly.
- This deviceDEN130013 Vitek MSbioMerieux, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK130831 Maldi Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK142677 MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK163536 MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017
- Descendant · cites it directly · 0 of its ownK162950 Vitek MSbioMerieux, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K130831Maldi Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc. · 2013 · cites it directly2descendants
- K142677MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015 · cites it directly1descendant
- K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017 · 2 generations on0descendants
- K162950Vitek MSbioMerieux, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130013 | Vitek MS | bioMerieux, Inc. | 2013 | — |
| +1 | K130831 | Maldi Biotyper CA (MBT-CA) System | Bruker Daltonics, Inc. | 2013 | — |
| +1 | K142677 | MALDI Biotyper CA System | Bruker Daltonics, Inc. | 2015 | — |
| +2 | K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Bruker Daltonik GmbH | 2017 | — |
| +1 | K162950 | Vitek MS | bioMerieux, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
3 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?
- Of its descendants, K130831 (Bruker Daltonics, Inc., 2013) has gone furthest, with 2 descendants of its own.
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. 2013, 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 | — |
https://510kreport.com/device/DEN130013 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130013: Vitek MS.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130013
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026