510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191967Substantially Equivalent

Unyvero LRT BAL Application

Curetis GmbH, Holzgerlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191967 is the FDA 510(k) clearance record for Unyvero LRT BAL Application, a class II device, cleared for Curetis GmbH on under FDA product code QBH (Lower Respiratory Microbial Nucleic Acid Detection System). FDA's definition for product code QBH reads: "Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens". FDA records list 2 510(k) clearances for Curetis GmbH, from to . As of , FDA records show no recalls naming K191967.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QBH Lower Respiratory Microbial Nucleic Acid Detection System
Regulation
21 CFR 866.3985
Device class
Class II
Review panel
Microbiology
Applicant
Curetis GmbH Max-Eyth-Straße 42, Holzgerlingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBH

Trailing 12 months

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

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