510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193419Substantially Equivalent

MBT Sepsityper

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

K193419 is the FDA 510(k) clearance record for MBT Sepsityper, a class II device, cleared for Bruker Daltonik GmbH on under FDA product code QNJ (Mass Spectrometry, Microorganism Identification, Blood Culture). FDA's definition for product code QNJ reads: "Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms...". FDA records list 3 510(k) clearances for Bruker Daltonik GmbH, from to . As of , FDA records show no recalls naming K193419.

Clearance record

Decision date
Received
(384 days to decision)
Product code
QNJ Mass Spectrometry, Microorganism Identification, Blood Culture
Regulation
21 CFR 866.3378
Device class
Class II
Review panel
Microbiology
Applicant
Bruker Daltonik GmbH Fahrenheitstrasse 4, Bremen, DE
510(k) summary
Statement
Third party review
No

Clearances, product code QNJ

Trailing 12 months

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

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