De Novo · Granted
GrantedMALDI Biotyper CA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bruker Daltonik GmbH · QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Granted on Apr 20, 2018 as a new device type through De Novo after a 203-day review. 5 later devices descend from it.
- Decided
- Apr 20, 2018
- Review
- 203 days
- Class
- Class II
- Product code
- QBN
- Recalls
- None
5 later devices descend from it, 3 citing it directly.
- This deviceDEN170081 MALDI Biotyper CA SystemBruker Daltonik GmbH · 2018
- Descendant · cites it directly · 2 of its ownK181412 Vitek MSbioMerieux, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK191964 BD Kiestra IdentifABecton, Dickinson and Company · 2021
- Descendant · 2 generations on · 0 of its ownK222563 BD Kiestra IdentifABecton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK212461 Vitek MS PrimebioMerieux, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK193138 Colibri SystemCopan Wasp Srl · 2021
Most influential descendants
Showing 5 of 5 · See all- K181412Vitek MSbioMerieux, Inc. · 2018 · cites it directly2descendants
- K191964BD Kiestra IdentifABecton, Dickinson and Company · 2021 · cites it directly1descendant
- K222563BD Kiestra IdentifABecton, Dickinson and Company · 2023 · 2 generations on0descendants
- K212461Vitek MS PrimebioMerieux, Inc. · 2022 · 2 generations on0descendants
- K193138Colibri SystemCopan Wasp Srl · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170081 | MALDI Biotyper CA System | Bruker Daltonik GmbH | 2018 | — |
| +1 | K181412 | Vitek MS | bioMerieux, Inc. | 2018 | — |
| +1 | K191964 | BD Kiestra IdentifA | Becton, Dickinson and Company | 2021 | — |
| +2 | K222563 | BD Kiestra IdentifA | Becton, Dickinson and Company | 2023 | — |
| +2 | K212461 | Vitek MS Prime | bioMerieux, Inc. | 2022 | — |
| +1 | K193138 | Colibri System | Copan Wasp Srl | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 QBN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBN device
- #1 K251495 MBT Compass HT CA Software; MBT FAST Shuttle…score 9.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K181412 (bioMerieux, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QBN devicesQBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QBN
Too few QBN 510(k)s in any year since 2007 to give a median.
Recalls per year · QBN
No recall names QBN since 2007.
Adverse event reports per year · QBN
2in 2025
MAUDE reports naming product code QBN, not matched to any one device; reports are not rates.
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 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 54 |
| 2021 | 0 | — | 0 | 163 |
| 2022 | 1 | — | 0 | 135 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. Bacteria…
Read the full statement (686 words)
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 Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
Bacteria:
Abiotrophia defectiva Achromobacter xylosoxidans
Acinetobacter baumannii / nosocomialis Acinetobacter calcoaceticus group
Acinetobacter haemolyticus Acinetobacter johnsonii
Acinetobacter junii Acinetobacter lwoffii
Acinetobacter ursingii Actinomyces europaeus
Actinomyces hyovaginalis Actinomyces meyeri
Actinomyces oris Actinomyces radingae
Actinotignum schaalii group Aerococcus sanguinicola
Aeromonas salmonicida Aeromonas hydrophila | caviae group
Aggregatibacter segnis Alcaligenes faecalis
Anaerococcus murdochii Anaerococcus vaginalis
Bacteroides fragilis Bacteroides nordii
Bacteroides salyersiae Bacteroides stercoris group
Bacteroides vulgatus group Bifidobacterium breve
Brevibacterium casei Brevundimonas diminuta group
Burkholderia multivorans Campylobacter coli
Capnocytophaga ochracea Capnocytophaga sputigena
Citrobacter amalonaticus complex Citrobacter freundii complex
Clostridium bifermentans Clostridium butyricum
Clostridium innocuum Clostridium paraputrificum
Clostridium septicum Clostridium sordellii
Corynebacterium accolens Corynebacterium afermentans group
Corynebacterium bovis Corynebacterium coyleae
Corynebacterium glucuronolyticum Corynebacterium glutamicum
Corynebacterium macginleyi Corynebacterium minutissimum
Corynebacterium pseudodiphtheriticum Corynebacterium pseudotuberculosis
Corynebacterium striatum group Corynebacterium tuberculostearicum
Corynebacterium xerosis Cronobacter sakazakii group
Dermabacter hominis Dermacoccus nishinomiyaensis
Elizabethkingia meningoseptica group Enterobacter aerogenes
Enterococcus avium Enterococcus casseliflavus
Enterococcus durans Enterococcus faecalis
Enterococcus faecium Enterococcus gallinarum
Enterococcus hirae Enterococcus mundtii
Enterococcus raffinosus Escherichia coli
Escherichia hermannii Escherichia vulneris
Ewingella americana Facklamia hominis
Finegoldia magna Fluoribacter bozemanae
Fusobacterium canifelinum Fusobacterium necrophorum
Fusobacterium nucleatum Gardnerella vaginalis
Gemella haemolysans Gemella morbillorum
Gemella sanguinis Granulicatella adiacens
Haemophilus haemolyticus Haemophilus influenzae
Haemophilus parahaemolyticus group Haemophilus parainfluenzae
Hafnia alvei Helcococcus kunzii
Kingella denitrificans Kingella kingae
Klebsiella oxytoca / Raoultella Klebsiella pneumoniae ornithinolytica
Klebsiella variicola Kocuria kristinae
Kytococcus sedentarius Lactobacillus gasseri
Lactobacillus jensenii Lactobacillus rhamnosus
Lactococcus garvieae Lactococcus lactis
Leclercia adecarboxylata Legionella longbeachae
Legionella pneumophila Leuconostoc citreum
Leuconostoc mesenteroides Leuconostoc pseudomesenteroides
Listeria monocytogenes Macrococcus caseolyticus
Mannheimia haemolytica group Micrococcus luteus
Micrococcus lylae Mobiluncus curtisii
Moraxella sg Branhamella catarrhalis* Moraxella sg Moraxella nonliquefaciens*
Moraxella sg Moraxella osloensis* Morganella morganii
Myroides odoratimimus Myroides odoratus
Neisseria bacilliformis Neisseria cinerea
Neisseria elongata Neisseria flavescens / subflava group
Neisseria gonorrhoeae Neisseria lactamica
Neisseria meningitidis Neisseria sicca group
Neisseria weaveri Nocardia brasiliensis
Nocardia cyriacigeorgica Nocardia farcinica group
Nocardia nova Nocardia otitidiscaviarum
Ochrobactrum anthropi Oligella ureolytica
Oligella urethralis Pantoea agglomerans
Parabacteroides distasonis Parabacteroides goldsteinii
Parabacteroides johnsonii / merdae group Parvimonas micra
Pasteurella multocida Pediococcus acidilactici
Pediococcus pentosaceus Peptoniphilus harei group
Peptostreptococcus anaerobius Plesiomonas shigelloides
Pluralibacter gergoviae Porphyromonas gingivalis
Porphyromonas somerae Prevotella bivia
Prevotella buccae Prevotella denticola
Prevotella intermedia Prevotella melaninogenica
Propionibacterium acnes Proteus mirabilis
Proteus vulgaris group Providencia rettgeri
Providencia stuartii Pseudomonas aeruginosa
Pseudomonas fluorescens group Pseudomonas oryzihabitans
Pseudomonas putida group Pseudomonas stutzeri
Ralstonia pickettii Rhizobium radiobacter
Rothia aeria Rothia dentocariosa
Rothia mucilaginosa Salmonella sp**
Serratia fonticola Serratia liquefaciens
Serratia marcescens Serratia odorifera
Serratia plymuthica Serratia rubidaea
Sphingobacterium multivorum Sphingobacterium spiritivorum
Sphingomonas paucimobilis group Staphylococcus aureus
Staphylococcus auricularis Staphylococcus capitis
Staphylococcus caprae Staphylococcus carnosus
Staphylococcus cohnii Staphylococcus delphini
Staphylococcus epidermidis Staphylococcus equorum
Staphylococcus felis Staphylococcus haemolyticus
Staphylococcus hominis Staphylococcus intermedius
Staphylococcus lentus Staphylococcus lugdunensis
Staphylococcus pasteuri Staphylococcus pettenkoferi
Staphylococcus pseudintermedius Staphylococcus saccharolyticus
Staphylococcus saprophyticus Staphylococcus schleiferi
Staphylococcus sciuri Staphylococcus simulans
Staphylococcus vitulinus Staphylococcus warneri
Staphylococcus xylosus Stenotrophomonas maltophilia
Streptococcus agalactiae Streptococcus anginosus
Streptococcus canis Streptococcus constellatus
Streptococcus dysgalactiae Streptococcus equi
Streptococcus gallolyticus Streptococcus gordonii
Streptococcus intermedius Streptococcus lutetiensis
Streptococcus mitis / oralis group Streptococcus mutans
Streptococcus parasanguinis Streptococcus pneumoniae
Streptococcus pyogenes Streptococcus salivarius / vestibularis group
Streptococcus sanguinis Streptococcus sobrinus
Streptococcus thermophilus Sutterella wadsworthensis
Trueperella bernardiae Turicella otitidis
Vagococcus fluvialis Veillonella parvula group
Vibrio parahaemolyticus Vibrio vulnificus
Weeksella virosa Yersinia enterocolitica
Yersinia frederiksenii Yersinia intermedia
Yersinia kristensenii Yersinia pseudotuberculosis
* = subgenus
sp** = species
Yeasts:
Candida albicans Candida auris
Candida boidinii Candida dubliniensis
Candida duobushaemulonii Candida famata
Candida glabrata Candida guilliermondii
Candida haemulonis Candida inconspicua
Candida intermedia Candida kefyr
Candida krusei Candida lambica
Candida lipolytica Candida lusitaniae
Candida metapsilosis Candida norvegensis
Candida orthopsilosis Candida parapsilosis
Candida pararugosa Candida pelliculosa
Candida tropicalis Candida valida
Candida zeylanoides Cryptococcus gattii
Cryptococcus neoformans var grubii* Cryptococcus neoformans var neoformans*
Cyberlindnera jadinii Geotrichum candidum
Geotrichum capitatum Kloeckera apiculata
Malassezia furfur Malassezia pachydermatis
Pichia ohmeri Rhodotorula mucilaginosa
Saccharomyces cerevisiae Trichosporon asahii
Trichosporon inkin Trichosporon mucoides group
* = variety
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/DEN170081 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170081: MALDI Biotyper CA System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170081
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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