510(k) · Cleared
ClearedVitek 2 Gram Negative Doripenem
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 Mar 16, 2009 as substantially equivalent to K072038 (bioMerieux, Inc., 2007) after a 213-day review. Its family tree reaches back 3 generations to 2003. 1 of the 26 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Mar 16, 2009
- Review
- 213 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032788 (2003). 22 later devices descend from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 2 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- 1 generation backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- This deviceK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- Descendant · cites it directly · 21 of its ownK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- Descendant · 2 generations on · 19 of its ownK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
- Descendant · 4 generations on · 5 of its ownK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
- Descendant · 5 generations on · 3 of its ownK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161217 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64…4 generations on · 2017
Most influential descendants
Showing 5 of 22 · See all- K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009 · cites it directly21descendants
- K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011 · 2 generations on19descendants
- K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012 · 3 generations on15descendants
- K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016 · 4 generations on5descendants
- K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −2 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| −1 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| 0 (this device) | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| +1 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| +2 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| +3 | K121546 | Vitek 2 Gram Negative Doxycycline | bioMerieux, Inc. | 2012 | — |
| +4 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | bioMerieux, Inc. | 2016 | — |
| +5 | K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | bioMerieux, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 | 3 | 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 |
|---|---|---|---|
| * | K072038 | Vitek 2 Gram Negative LevofloxacinSummary page 1…866.1645 Common Name: VITEK 2 AST-GN Doripenem C. Predicate Device: V1TEK 2 Gram Negative Levofloxacin (K072038) D. 510(k) Summary: VITEKI 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negati… | 2007 |
| † | K050002 | Vitek 2 Compact | 2005 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091899 | Vitek 2 Gram Negative Meropenem | 2009 | 21 |
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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091899 (bioMerieux, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K072038.
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. 2009, 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?
VITEKO 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negative 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 Gram Negative is a quantitative test. Doripenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.…
Read the full statement (152 words)
VITEKO 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negative 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 Gram Negative is a quantitative test. Doripenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Acinetobacter baumannii
Escherichia coli
Klebsiella pneumoniae
Proteus mirabifis
Pseudomonas aeruginosa
Active in vitro but clinical significance unknown:
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Kiebsiella oxytoca
Serratia marcescens
The VITEKe 2 Antimicrobial Susceptibility Test (AST):is intended to be used with the VITEKe 2 and VITEKe 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/K082346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082346: Vitek 2 Gram Negative Doripenem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082346
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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