# Bruker Daltonik GmbH

- Location (FDA's records): Bremen, DE
- FDA decisions: 3 (2017–2020): 2 510(k) clearances and 1 De Novo grant
- Product codes: QNJ (1), PEX (1), QBN (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 5 (0 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
- Bruker Daltonics, Inc.: 1 (https://510kreport.com/company/bruker-daltonics)

## Firms that cite its devices most
- Bruker Daltonics, Inc.: 1 (https://510kreport.com/company/bruker-daltonics)
- Accelerate Diagnostics, Inc.: 1 (https://510kreport.com/company/accelerate-diagnostics)
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Copan Wasp Srl: 1 (https://510kreport.com/company/copan-wasp)

## Its most-cited devices
- DEN170081: MALDI Biotyper CA System (2018), cited by 3
- K193419: MBT Sepsityper (2020), cited by 2

## Recent decisions
- K193419: MBT Sepsityper (Dec 27, 2020)
- DEN170081: MALDI Biotyper CA System (Apr 20, 2018)
- K163536: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (Jul 26, 2017)

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