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Bruker Daltonics: FDA-registered device maker in Bremen, Germany, 5 510(k) clearances

Name: Bruker Daltonics FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bruker Daltonics is registered with the FDA (registration 3010191749) in Bremen, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 13, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010191749
Address: Fahrenheitstrasse 4, Bremen, Germany, 28359
Owner or operator: Bruker Scientific LLC (10044152)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: December 12, 2013
Registered through: 2027
Brand names listed: BD Bruker MALDI Biotyper CA System, BD Bruker MBT-CA System, MALDI Biotyper CA System, MALDI Biotyper sirius CA System, MALDI Biotyper sirius one CA System, MALDI Biotyper-BD sirius CA System, MALDI Biotyper-BD sirius one CA System, MBT Biotarget 96 US IVD and more

Devices it lists

Device	Product code	Class	Role	Source
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	QBN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mass Spectrometry, Microorganism Identification, Blood Culture	QNJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	PEX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 13, 2025	K251495	MBT Compass HT CA Software; MBT FAST Shuttle US IVD	QBN	Substantially Equivalent	Bruker Daltonics GmbH & Co. KG	accessdata.fda.gov
December 27, 2020	K193419	MBT Sepsityper	QNJ	Substantially Equivalent	Bruker Daltonik GmbH	accessdata.fda.gov
July 26, 2017	K163536	MALDI Biotyper CA (MBT-CA) System, MBT smart CA System	PEX	Substantially Equivalent	Bruker Daltonik GmbH	accessdata.fda.gov
March 27, 2015	K142677	MALDI Biotyper CA System	PEX	Substantially Equivalent	Bruker Daltonics, Inc.	accessdata.fda.gov
November 21, 2013	K130831	MALDI BIOTYPER CA (MBT-CA) SYSTEM	PEX	Substantially Equivalent	Bruker Daltonics, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.