510(k) · Cleared
ClearedVitek 2 Gram Negative Levofloxacin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Sep 12, 2007 as substantially equivalent to K041982 (bioMerieux, Inc., 2004) after a 49-day review. Its family tree reaches back 2 generations to 2003. 1 of the 29 devices in its family, counting itself, has a Class I recall. 26 later devices descend from it.
- Decided
- Sep 12, 2007
- Review
- 49 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032788 (2003). 26 later devices descend from it, 4 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 1 generation backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- This deviceK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- Descendant · cites it directly · 22 of its ownK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- Descendant · 2 generations on · 21 of its ownK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- Descendant · 3 generations on · 19 of its ownK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- Descendant · 4 generations on · 15 of its ownK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
- Descendant · 5 generations on · 5 of its ownK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161217 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64…5 generations on · 2017
Most influential descendants
Showing 5 of 26 · See all- K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009 · cites it directly22descendants
- K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009 · 2 generations on21descendants
- K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011 · 3 generations on19descendants
- K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012 · 4 generations on15descendants
- K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −1 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| 0 (this device) | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| +1 | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| +2 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| +3 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| +4 | K121546 | Vitek 2 Gram Negative Doxycycline | bioMerieux, Inc. | 2012 | — |
| +5 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | bioMerieux, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 9 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 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.
1 device in this family has a Class I recall. 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
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 | Decided |
|---|---|---|---|
| * | K041982 | Vitek 2 Gram Negative ErtapenemSummary page 1…R 866. 1645 Common Name: VITEK 2 AST-GN Levofioxacin C. Predicate Device: VITEK 2 Gram Negative Ertapenemn (K041982). D. 510(k) Summary: VITEKe 2 Gram Negative Levofioxacin is designed for antimicrobial susceptibility testing of Entemoba… | 2004 |
| † | K050002 | Vitek 2 Compact | 2005 |
What descends from it? (26)
See all 264 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082346 (bioMerieux, Inc., 2009) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K041982.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 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 Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri…
Read the full statement (136 words)
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens.
VITEK 2 Gram Negative Levofloxacin is a quantitative test. It 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.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072038: Vitek 2 Gram Negative Levofloxacin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072038
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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