# Bruker Daltonics, Inc.

- Location (FDA's records): Bremen, DE
- FDA decisions: 3 (2013–2025): 3 510(k) clearances
- Names in FDA's records: Bruker Daltonics, Inc. (2); Bruker Daltonics GmbH & Co. KG (1)
- Product codes: PEX (2), QBN (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- bioMerieux, Inc.: 2 (https://510kreport.com/company/biomerieux)
- Bruker Daltonik GmbH: 1 (https://510kreport.com/company/bruker-daltonik)

## Firms that cite its devices most
- Bruker Daltonik GmbH: 1 (https://510kreport.com/company/bruker-daltonik)

## Its most-cited devices
- K130831: Maldi Biotyper CA (MBT-CA) System (2013), cited by 1
- K142677: MALDI Biotyper CA System (2015), cited by 1

## Recent decisions
- K251495: MBT Compass HT CA Software; MBT FAST Shuttle US IVD (Aug 13, 2025)
- K142677: MALDI Biotyper CA System (Mar 27, 2015)
- K130831: Maldi Biotyper CA (MBT-CA) System (Nov 21, 2013)

Source page: https://510kreport.com/company/bruker-daltonics