510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251495Substantially Equivalent

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Bruker Daltonics GmbH & Co. KG, Bremen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251495 is the FDA 510(k) clearance record for MBT Compass HT CA Software; MBT FAST Shuttle US IVD, a class II device, cleared for Bruker Daltonics GmbH & Co. KG on under FDA product code QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates). FDA's definition for product code QBN reads: "The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI...". FDA records list one 510(k) clearance for Bruker Daltonics GmbH & Co. KG. As of , FDA records show no recalls naming K251495.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Regulation
21 CFR 866.3378
Device class
Class II
Review panel
Microbiology
Applicant
Bruker Daltonics GmbH & Co. KG Fahrenheitstraße 4, Bremen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBN

Trailing 12 months

FDA records hold no clearances under product code QBN in the trailing twelve months.

FDA records show no clearances under product code QBN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260