510(k) · Cleared
ClearedMALDI Biotyper CA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bruker Daltonics, Inc. · PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Cleared on Mar 27, 2015 as substantially equivalent to DEN130013 (bioMerieux, Inc., 2013) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 2013. 1 later device descends from it.
- Decided
- Mar 27, 2015
- Review
- 189 days
- Class
- Class II
- Product code
- PEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN130013 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN130013 Vitek MSbioMerieux, Inc. · 2013
- 1 generation backK130831 Maldi Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc. · 2013
- This deviceK142677 MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK163536 MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130013 | Vitek MS | bioMerieux, Inc. | 2013 | — |
| −1 | K130831 | Maldi Biotyper CA (MBT-CA) System | Bruker Daltonics, Inc. | 2013 | — |
| 0 (this device) | K142677 | MALDI Biotyper CA System | Bruker Daltonics, Inc. | 2015 | — |
| +1 | K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Bruker Daltonik GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | DEN130013 | Vitek MS Our reading of the summary gave K124067, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130013, Vitek MS (bioMerieux, Inc.), granted Aug 21, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
| * | K130831 | Maldi Biotyper CA (MBT-CA) SystemSummary page 9…valency The Bruker Daltonics, Inc. MBT-CA System is substantially equivalent to the bioMérieux Vitek MS (K124067) and the Bruker Daltonics, Inc. MBT-CA System (K130831). Table 1 compares the characteristics of the MBT-CA System (New Device) and the Vitek MS (Predicate Device). Table 1. Subst… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | 2017 | 0 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163536 (Bruker Daltonik GmbH, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate DEN130013.
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. 2015, 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 Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system 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. BACTERIA…
Read the full statement (523 words)
The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system 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.
BACTERIA
Achromobacter xylosoxidans
Acinetobacter baumannii complex [4]
Acinetobacter haemolyticus
Acinetobacter johnsonii
Acinetobacter junii
Acinetobacter lwoffii
Acinetobacter radioresistens
Acinetobacter ursingii
Actinomyces meyeri
Actinomyces neuii
Actinomyces odontolyticus
Actinomyces oris
Aerococcus urinae
Aerococcus viridans
Aeromonas salmonicida
Aeromonas sp[7]
Alcaligenes faecalis
Anaerococcus vaginalis
Bacteroides fragilis
Bacteroides ovatus group
Bacteroides thetaiotaomicron group
Bacteroides uniformis
Bacteroides vulgatus group
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 difficile
Clostridium perfringens
Corynebacterium amycolatum
Corynebacterium aurimucosum group
Corynebacterium bovis
Corynebacterium diphtheriae
Corynebacterium glucuronolyticum
Corynebacterium jeikeium
Corynebacterium kroppenstedtii
Corynebacterium macginleyi
Corynebacterium minutissimum
Corynebacterium propinquum
Corynebacterium pseudodiphtheriticum
Corynebacterium riegelii
Corynebacterium striatum group
Corynebacterium tuberculostearicum
Corynebacterium ulcerans
Corynebacterium urealyticum
Corynebacterium xerosis
Cronobacter sakazakii group
Cupriavidus pauculus group
Delftia acidovorans group
Dermacoccus nishinomiyaensis
Edwardsiella tarda
Eikenella corrodens
Elizabethkingia meningoseptica group
Enterobacter aerogenes
Enterobacter amnigenus
Enterobacter cloacae complex
Enterococcus avium group
Enterococcus casseliflavus
Enterococcus faecalis
Enterococcus faecium
Enterococcus gallinarum
Enterococcus hirae
Escherichia coli
Finegoldia magna
Fusobacterium canifelinum
Fusobacterium necrophorum
Fusobacterium nucleatum
Gardnerella vaginalis
Gemella haemolysans
Gemella sanguinis
Granulicatella adiacens
Haemophilus haemolyticus
Haemophilus influenzae
Haemophilus parahaemolyticus group
Haemophilus parainfluenzae
Hafnia alvei
Kingella kingae
Klebsiella oxytoca / Raoultella ornithinolytica
Klebsiella pneumoniae
Kocuria kristinae
Kytococcus sedentarius
Lactococcus garvieae
Lactococcus lactis
Leuconostoc mesenteroides
Macrococcus caseolyticus
Micrococcus luteus
Moraxella sg Branhamella catarrhalis
Moraxella sg Moraxella nonliquefaciens
Moraxella sg Moraxella osloensis
Morganella morganii
Myroides odoratimimus
Myroides odoratus
Oligella ureolytica
Oligella urethralis
Pantoea agglomerans
Parabacteroides distasonis
Pasteurella multocida
Pediococcus pentosaceus
Peptoniphilus harei group
Peptostreptococcus anaerobius
Plesiomonas shigelloides
Porphyromonas gingivalis
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
Rhizobium radiobacter
Rothia aeria
Rothia dentocariosa
Rothia mucilaginosa
Salmonella sp
Serratia liquefaciens
Serratia marcescens
Serratia plymuthica
Serratia rubidaea
Staphylococcus aureus
Staphylococcus auricularis
Staphylococcus capitis
Staphylococcus caprae
Staphylococcus carnosus
Staphylococcus cohnii
Staphylococcus epidermidis
Staphylococcus equorum
Staphylococcus felis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus lugdunensis
Staphylococcus pasteuri
Staphylococcus pettenkoferi
Staphylococcus pseudintermedius
Staphylococcus saccharolyticus
Staphylococcus saprophyticus
Staphylococcus schleiferi
Staphylococcus simulans
Staphylococcus vitulinus
Staphylococcus warneri
Stenotrophomonas maltophilia
Streptococcus agalactiae
Streptococcus anginosus
Streptococcus constellatus
Streptococcus dysgalactiae
Streptococcus gallolyticus
Streptococcus gordonii
Streptococcus intermedius
Streptococcus lutetiensis
Streptococcus mitis / oralis group
Streptococcus mutans
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus salivarius
Sutterella wadsworthensis
Vibrio parahaemolyticus
Vibrio vulnificus
Yersinia enterocolitica
Yersinia pseudotuberculosis
YEAST
Candida albicans
Candida boidinii
Candida dubliniensis
Candida duobushaemulonii
Candida famata
Candida glabrata
Candida guilliermondii
Candida haemulonis
Candida inconspicua
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
Cryptococcus gattii
Cryptococcus neoformans var grubii
Cryptococcus neoformans var neoformans
Geotrichum candidum
Geotrichum capitatum
Kloeckera apiculata
Pichia ohmeri
Saccharomyces cerevisiae
Trichosporon asahii
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142677: MALDI Biotyper CA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142677
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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