510(k) · Cleared
ClearedMALDI Biotyper CA (MBT-CA) System, MBT smart CA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bruker Daltonik GmbH · PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Cleared on Jul 26, 2017 as substantially equivalent to K142677 (Bruker Daltonics, Inc., 2015) after a 222-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Jul 26, 2017
- Review
- 222 days
- Class
- Class II
- Product code
- PEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130013 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backDEN130013 Vitek MSbioMerieux, Inc. · 2013
- 2 generations backK130831 Maldi Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc. · 2013
- 1 generation backK142677 MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015
- This deviceK163536 MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130013 | Vitek MS | bioMerieux, Inc. | 2013 | — |
| −2 | K130831 | Maldi Biotyper CA (MBT-CA) System | Bruker Daltonics, Inc. | 2013 | — |
| −1 | K142677 | MALDI Biotyper CA System | Bruker Daltonics, Inc. | 2015 | — |
| 0 (this device) | K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Bruker Daltonik GmbH | 2017 | — |
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 PEX? 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 |
|---|---|---|---|
| * | K142677 | MALDI Biotyper CA SystemSummary page 12…Class II Panel: Microbiology Substantial Equivalency The MBT-CA System (K163536) is substantially equivalent to the MBT-CA System (K142677). Table 1 compares the characteristics of the MBT-CA System (New Device) and the MBT-CA System (Predicate Device). Table 1: Subs… | 2015 |
| † | K130831 | Maldi Biotyper CA (MBT-CA) System | 2013 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All PEX devicesPEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PEX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PEX
Too few PEX 510(k)s in any year since 2007 to give a median.
Recalls per year · PEX
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEX
4in 2021
MAUDE reports naming product code PEX, 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 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 2 | — | 0 | 94 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 107 |
| 2020 | 0 | — | 0 | 89 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification 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 yeast infections. The following organisms are claimed…
Read the full statement (809 words)
The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification 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 yeast infections.
The following organisms are claimed:
Bacteria:
Abiotrophia defectiva
Achromobacter xylosoxidans
Acinetobacter baumannii / nosocomialis group
Acinetobacter calcoaceticus
Acinetobacter haemolyticus
Acinetobacter johnsonii
Acinetobacter junii
Acinetobacter lwoffii
Acinetobacter pittii
Acinetobacter radioresistens
Acinetobacter ursingii
Actinomyces europaeus
Actinomyces funkei
Actinomyces graevenitzii
Actinomyces hyovaginalis
Actinomyces meyeri
Actinomyces neuii
Actinomyces odontolyticus
Actinomyces oris
Actinomyces radingae
Actinomyces turicensis
Actinomyces urogenitalis
Actinotignum schaalii group
Aerococcus sanguinicola
Aerococcus urinae
Aerococcus viridans
Aeromonas salmonicida
Aeromonas sp[7]
Aggregatibacter actinomycetemcomitans
Aggregatibacter aphrophilus
Aggregatibacter segnis
Alcaligenes faecalis
Alloiococcus otitis
Alloscardovia omnicolens
Anaerococcus murdochii
Anaerococcus vaginalis
Arthrobacter cumminsii
Bacteroides caccae
Bacteroides fragilis
Bacteroides nordii
Bacteroides ovatus group
Bacteroides pyogenes
Bacteroides salyersiae
Bacteroides stercoris group
Bacteroides thetaiotaomicron group
Bacteroides uniformis
Bacteroides vulgatus group
Bifidobacterium breve
Bordetella group[3]
Bordetella hinzii
Brevibacterium casei
Brevundimonas diminuta group
Burkholderia cepacia complex [13]
Burkholderia gladioli
Burkholderia multivorans
Campylobacter coli
Campylobacter jejuni
Campylobacter ureolyticus
Capnocytophaga ochracea
Capnocytophaga sputigena
Chryseobacterium gleum
Chryseobacterium indologenes
Citrobacter amalonaticus complex
Citrobacter freundii complex
Citrobacter koseri
Clostridium beijerinckii
Clostridium bifermentans
Clostridium butyricum
Clostridium clostridioforme group
Clostridium difficile
Clostridium innocuum
Clostridium paraputrificum
Clostridium perfringens
Clostridium ramosum
Clostridium septicum
Clostridium sordellii
Clostridium sporogenes / Clostridium botulinum (group I)
Clostridium tertium
Corynebacterium accolens
Corynebacterium afermentans group
Corynebacterium amycolatum
Corynebacterium aurimucosum group
Corynebacterium bovis
Corynebacterium coyleae
Corynebacterium diphtheriae
Corynebacterium freneyi
Corynebacterium glucuronolyticum
Corynebacterium glutamicum
Corynebacterium jeikeium
Corynebacterium kroppenstedtii
Corynebacterium macginleyi
Corynebacterium minutissimum
Corynebacterium mucifaciens / ureicelerivorans group
Corynebacterium propinquum
Corynebacterium pseudodiphtheriticum
Corynebacterium pseudotuberculosis
Corynebacterium resistens
Corynebacterium riegelii
Corynebacterium striatum group
Corynebacterium tuberculostearicum
Corynebacterium ulcerans
Corynebacterium urealyticum
Corynebacterium xerosis
Cronobacter sakazakii group
Cupriavidus pauculus group
Delftia acidovorans group
Dermabacter hominis
Dermacoccus nishinomiyaensis
Edwardsiella tarda
Eikenella corrodens
Elizabethkingia meningoseptica group
Enterobacter aerogenes
Enterobacter amnigenus
Enterobacter cloacae complex
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 ornithinolytica
Klebsiella pneumoniae
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
*sg = subgenus
**sp = species
Yeasts:
Candida albicans
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
*var = variety
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163536: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163536
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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