510(k) · Cleared

Cleared

Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae

K031865510(k) TraditionalCleared Aug 13, 200357-day reviewClass II21 CFR 866.1645

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

bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Aug 13, 2003 after a 57-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 26 later devices descend from it.

Decided: Aug 13, 2003
Review: 57 days
Class: Class II
Product code: LON
Recalls: None
Predicates: 1

26 later devices descend from it, 2 citing it directly.

This deviceK031865 Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc. · 2003
Descendant · cites it directly · 24 of its ownK053186 Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005
Descendant · 2 generations on · 20 of its ownK063597 Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007
Descendant · 3 generations on · 3 of its ownK112000 Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011
Descendant · 4 generations on · 2 of its ownK232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
Descendant · 3 generations on · 2 of its ownK121863 Vitek 2 Ast-ST CefotaximebioMerieux, Inc. · 2012

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005high 7 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 26 · See all

K053186Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005 · cites it directly24descendants
K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007 · 2 generations on20descendants
K112000Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011 · 3 generations on3descendants
K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…bioMerieux, Inc. · 2023 · 4 generations on2descendants
K121863Vitek 2 Ast-ST CefotaximebioMerieux, Inc. · 2012 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031865	Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae	bioMerieux, Inc.	2003	—
+1	K053186	Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae	bioMerieux, Inc.	2005	—
+2	K063597	Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae	bioMerieux, Inc.	2007	—
+3	K112000	Vitek 2 Streptococcus Penicillin	bioMerieux, Inc.	2011	—
+4	K232201	VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…	bioMerieux, Inc.	2023	—
+3	K121863	Vitek 2 Ast-ST Cefotaxime	bioMerieux, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	2	0
2009	1	0
2011	5	0
2012	7	0
2013	3	0
2021	1	0
2023	2	0
2026	2	0

FIG. 1 — Lineage of K031865, 2003–2026Source: 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 LON? 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 LON device

#1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K050510	FDA’s K050510 is Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Shimadzu Medical Systems	2005	—

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053186	Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae	bioMerieux, Inc.	2005	24
K051849	Vitek 2 Gram Positive Ertapenem for Streptococcus Pneumoniae	bioMerieux, Inc.	2005	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?

Of its descendants, K053186 (bioMerieux, Inc., 2005) has gone furthest, with 24 descendants of its own.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LON

5in 2025

2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007high 268 (2021) · low 50 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LON

1in 2025

2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, 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	19	50	0	3
2008	7	66	1	1
2009	8	76	0	0
2010	1	—	116	3
2011	8	85	3	4
2012	10	200	3	9
2013	7	115	0	3
2014	4	90	2 (2)	10
2015	0	—	0	41
2016	3	242	2	94
2017	10	89	1	197
2018	4	88	6	512
2019	8	84	1	315
2020	5	81	8	218
2021	5	268	0	232
2022	8	189	15	180
2023	11	210	0	453
2024	2	—	1	418
2025	5	90	1	690
2026	4	146	6	—

What is it indicated for?

VITEK@2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK? 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031865 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031865: Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031865

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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