510(k) · Cleared

Cleared

Maldi Biotyper CA (MBT-CA) System

K130831510(k) TraditionalCleared Nov 21, 2013240-day reviewClass II21 CFR 866.3361

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bruker Daltonics, Inc. · PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Cleared on Nov 21, 2013 as substantially equivalent to DEN130013 (bioMerieux, Inc., 2013) after a 240-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.

Decided: Nov 21, 2013
Review: 240 days
Class: Class II
Product code: PEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN130013 (2013). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN130013 Vitek MSbioMerieux, Inc. · 2013
This deviceK130831 Maldi Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc. · 2013
Descendant · cites it directly · 1 of its ownK142677 MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK163536 MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017

Most influential descendants

Showing 2 of 2 · See all

K142677MALDI Biotyper CA SystemBruker Daltonics, Inc. · 2015 · cites it directly1descendant
K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN130013	Vitek MS	bioMerieux, Inc.	2013	—
0 (this device)	K130831	Maldi Biotyper CA (MBT-CA) System	Bruker Daltonics, Inc.	2013	—
+1	K142677	MALDI Biotyper CA System	Bruker Daltonics, Inc.	2015	—
+2	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
2015	1	0
2017	1	0

FIG. 1 — Lineage of K130831, 2013–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	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.	bioMerieux, Inc.	2013	—

Also cleared against DEN130013: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142677	MALDI Biotyper CA System	Bruker Daltonics, Inc.	2015	1

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.
Of its descendants, K142677 (Bruker Daltonics, Inc., 2015) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate DEN130013.

How does its category compare?

All PEX devices

PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PEX

2in 2017

2007high 2 (2013) · low 0 (2007)2026

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

2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PEX

4in 2021

2007high 107 (2019) · low 0 (2007)2025

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 indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130831 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130831: Maldi Biotyper CA (MBT-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/K130831

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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