510(k) · Cleared
ClearedUnyvero LRT BAL Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curetis GmbH · QBH Lower Respiratory Microbial Nucleic Acid Detection System
Cleared on Dec 20, 2019 as substantially equivalent to DEN170047 (Curetis GmbH, 2018) after a 150-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Dec 20, 2019
- Review
- 150 days
- Class
- Class II
- Product code
- QBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170047 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170047 Curetis Unyvero LRT ApplicationCuretis GmbH · 2018
- This deviceK191967 Unyvero LRT BAL ApplicationCuretis GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170047 | Curetis Unyvero LRT Application | Curetis GmbH | 2018 | — |
| 0 (this device) | K191967 | Unyvero LRT BAL Application | Curetis GmbH | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170047 | Curetis Unyvero LRT ApplicationSummary page 5…nyvero LRT BAL Application is substantially equivalent to its predecessor test system, the Unyvero LRT Application (Curetis, GmbH, Germany), granted de novo status under DEN170047 on April 3rd, 2018. 807.92 (a)(4): Device Description The Unyvero LRT BAL Application automates and integrates DNA purification… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN170047.
How does its category compare?
All QBH devicesQBH Lower Respiratory Microbial Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QBH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QBH
Too few QBH 510(k)s in any year since 2007 to give a median.
Recalls per year · QBH
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QBH
No MAUDE report names QBH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Unyvero LRT BAL Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms (N = 20) and antibiotic resistance markers (N = 10) in bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) from adult hospitalized patients with suspected lower respiratory tract infections. Microorganism Associated Antibiotic Resistance Marker…
Read the full statement (471 words)
The Unyvero LRT BAL Application is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of nucleic acid sequences from the following microorganisms (N = 20) and antibiotic resistance markers (N = 10) in bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) from adult hospitalized patients with suspected lower respiratory tract infections.
Microorganism Associated Antibiotic Resistance Marker
Acinetobacter spp. a ctx-M b, kpc, ndm, oxa-23, oxa-24, oxa-58, vim
Chlamydia pneumoniae -
Citrobacter freundii ctx-M b, kpc, ndm, oxa-48, vim
Enterobacter cloacae complex c ctx-M b, kpc, ndm, oxa-48, vim
Escherichia coli ctx-M b, kpc, ndm, oxa-48, vim
Haemophilus influenzae tem
Klebsiella oxytoca ctx-M b, kpc, ndm, oxa-48, vim
Klebsiella pneumoniae d ctx-M b, kpc, ndm, oxa-48, vim
Klebsiella variicola ctx-M b, kpc, ndm, oxa-48, vim
Legionella pneumophila -
Moraxella catarrhalis -
Morganella morganii ctx-M b, kpc, ndm, oxa-48, vim
Mycoplasma pneumoniae -
Pneumocystis jirovecii -
Proteus spp. e ctx-M b, kpc, ndm, oxa-48, vim
Pseudomonas aeruginosa ctx-M b, kpc, ndm, vim
Serratia marcescens ctx-M b, kpc, ndm, oxa-48, vim
Staphylococcus aureus mecA
Stenotrophomonas maltophilia -
Streptococcus pneumoniae -
a Acinetobacter spp. includes: A. baumannii, A. calcoaceticus, A. haemolyticus, A. junii, A. lwoffii, A. nosocomialis, A. parvus, A. pittii (detected by LRT BAL Application) and A. ursingii (not detected by LRT BAL Application).
b ctx-M1 subgroup.
c Enterobacter cloacae complex includes: E. asburiae, E. chengduensis, E. chuandaensis, E. cloacae, E. hormaechei (incl. ssp. xiangfangensis), E. kobei, E. ludwigii, E. roggenkampii, E. sichuanensis as well as E. bugandensis (not yet recognized as member of the E. cloacae complex).
d Klebsiella pneumoniae includes two variants: K. pneumoniae (variant 1), and K. quasipneumoniae (variant 2).
e Proteus spp. includes P. cibarius, P. hauseri, P. mirabilis, P. penneri and P. vulgaris.
The Unyvero LRT BAL Application performed on the Unyvero System is indicated as an aid in the diagnosis of lower respiratory tract infection in adult hospitalized patients with signs and symptoms of lower respiratory infection; results should be used in conjunction with other clinical and laboratory findings. As BAL specimens may contain colonizing microorganisms, detection of Unyvero LRT BAL microbial targets does not indicate that the microorganism is the cause of the disease. Unyvero positive results do not rule out co-infection with other microorganisms. Negative results do not preclude lower respiratory infection, as the causative agent may be a microorganism not detected by this test.
A negative result for any antibiotic resistance marker does not indicate that detected microorganisms are susceptible to applicable antimicrobial agents. Detected antibiotic resistance markers cannot be definitively linked to specific microorganisms, and may be present in organisms that are not detected by the Unyvero LRT BAL Application.
Microbiology cultures of BALs should be performed to obtain isolates for species identification and antimicrobial susceptibility testing and to identify potential microorganisms not targeted by the Unyvero LRT BAL Application.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191967: Unyvero LRT BAL Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026