510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163536Substantially Equivalent

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System

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

K163536 is the FDA 510(k) clearance record for MALDI Biotyper CA (MBT-CA) System, MBT smart CA System, a class II device, cleared for Bruker Daltonik GmbH on under FDA product code PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates). FDA's definition for product code PEX reads: "A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens". FDA records list 3 510(k) clearances for Bruker Daltonik GmbH, from to . As of , FDA records show no recalls naming K163536.

Clearance record

Decision date
Received
(222 days to decision)
Product code
PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Regulation
21 CFR 866.3361
Device class
Class II
Review panel
Microbiology
Applicant
Bruker Daltonik GmbH Fahrenheitstrasse 4, Bremen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEX

Trailing 12 months

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

FDA records show no clearances under product code PEX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEX, 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