# DEN130013: Vitek MS

- Pathway: De Novo (Direct)
- Applicant: bioMerieux, Inc.
- Decided: Aug 21, 2013 after 231 days
- Product code: PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates)
- Device class: 2
- Regulation: 21 CFR 866.3361
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K130831: Maldi Biotyper CA (MBT-CA) System (2013), 2 descendants of its own
- K142677: MALDI Biotyper CA System (2015), 1 descendant of its own
- K163536: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (2017), 0 descendants of its own
- K162950: Vitek MS (2017), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130013
Methodology: https://510kreport.com/methodology