510(k) · Cleared

Cleared

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

K230864510(k) TraditionalCleared Jul 5, 202398-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 Jul 5, 2023 as substantially equivalent to K091126 (bioMerieux, Inc., 2009) after a 98-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.

Decided: Jul 5, 2023
Review: 98 days
Class: Class II
Product code: LON
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K032766 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK032766 Vitek 2 Gram Positive LinezolidbioMerieux, Inc. · 2003
3 generations backK050075 Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2005
2 generations backK072668 Vitek 2 Gram Positive VancomycinbioMerieux, Inc. · 2007
1 generation backK091126 Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2009
This deviceK230864 VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
Descendant · cites it directly · 0 of its ownK234000 VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all

K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K032766	Vitek 2 Gram Positive Linezolid	bioMerieux, Inc.	2003	—
−3	K050075	Vitek 2 Gram Positive Daptomycin	bioMerieux, Inc.	2005	—
−2	K072668	Vitek 2 Gram Positive Vancomycin	bioMerieux, Inc.	2007	—
−1	K091126	Vitek 2 Gram Positive Daptomycin	bioMerieux, Inc.	2009	—
0 (this device)	K230864	VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP…	bioMerieux, Inc.	2023	—
+1	K234000	VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)	bioMerieux, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K230864, 2003–2024Source: 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

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
*	K091126	Vitek 2 Gram Positive Daptomycin Summary page 4 …VITEK® 2 AST-GP Daptomycin C. Predicate Device: VITEK® 2 AST-GP Daptomycin (≤0.12 - ≥8 μg/mL) (K091126) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration…	bioMerieux, Inc.	2009	—

Also cleared against K091126: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K234000	VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)	bioMerieux, Inc.	2024	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 20 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K234000 (bioMerieux, Inc., 2024) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K091126.

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. 2023, this device’s year, is highlighted.

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 AST-Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Daptomycin is a quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below, according to…

Read the full statement (150 words)

VITEK® 2 AST-Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Gram positive

microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the

determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Daptomycin is a

quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below,

according to the FDA label for this antimicrobial.

Active both in vitro and in clinical infections:

Enterococcus faecalis (vancomycin-susceptible isolates only)

Staphylococcus aureus (including methicillin-resistant isolates)

In vitro data are available, but their clinical significance is unknown:

Enterococcus faecalis (vancomycin-resistant isolates)

The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical

laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.

agalactiae to antimicrobial agents when used as instructed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K230864 · printed Nov 4, 2026

Cite this page

510(k) Report. “K230864: VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230864

Report an extraction error

Are you the manufacturer?

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