510(k) · Cleared

Cleared

Vitek 2 Gram Positive Linezolid

K032766510(k) TraditionalCleared Oct 31, 200356-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 Oct 31, 2003 after a 56-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 14 later devices descend from it.

Decided: Oct 31, 2003
Review: 56 days
Class: Class II
Product code: LON
Recalls: None
Predicates: 1

14 later devices descend from it, 3 citing it directly.

This deviceK032766 Vitek 2 Gram Positive LinezolidbioMerieux, Inc. · 2003
Descendant · cites it directly · 6 of its ownK050075 Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2005
Descendant · cites it directly · 5 of its ownK122547 Gram Postitve ClindamycinbioMerieux, Inc. · 2012
Descendant · 2 generations on · 4 of its ownK141149 Vitek 2 Ast GP CeftarolinebioMerieux, Inc. · 2014
Descendant · 2 generations on · 4 of its ownK072668 Vitek 2 Gram Positive VancomycinbioMerieux, Inc. · 2007
Descendant · 3 generations on · 3 of its ownK190616 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc. · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005high 2 (2007) · low 0 (2006)2026

Most influential descendants

Showing 5 of 14 · See all

K050075Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2005 · cites it directly6descendants
K122547Gram Postitve ClindamycinbioMerieux, Inc. · 2012 · cites it directly5descendants
K141149Vitek 2 Ast GP CeftarolinebioMerieux, Inc. · 2014 · 2 generations on4descendants
K072668Vitek 2 Gram Positive VancomycinbioMerieux, Inc. · 2007 · 2 generations on4descendants
K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc. · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032766	Vitek 2 Gram Positive Linezolid	bioMerieux, Inc.	2003	—
+1	K050075	Vitek 2 Gram Positive Daptomycin	bioMerieux, Inc.	2005	—
+1	K122547	Gram Postitve Clindamycin	bioMerieux, Inc.	2012	—
+2	K141149	Vitek 2 Ast GP Ceftaroline	bioMerieux, Inc.	2014	—
+2	K072668	Vitek 2 Gram Positive Vancomycin	bioMerieux, Inc.	2007	—
+3	K190616	VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)	bioMerieux, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2009	1	0
2010	1	0
2012	1	0
2014	1	0
2019	1	0
2020	1	0
2021	1	0
2022	2	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K032766, 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; 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? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K050075	Vitek 2 Gram Positive Daptomycin	bioMerieux, Inc.	2005	6
K122547	Gram Postitve Clindamycin	bioMerieux, Inc.	2012	5
K212849	VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)	Biomérieux, Inc.	2022	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, K050075 (bioMerieux, Inc., 2005) has gone furthest, with 6 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 Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyficus and Streptococcus agalactiae. 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/K032766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032766: Vitek 2 Gram Positive Linezolid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032766

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