510(k) · Cleared
Recalled · Class II · 2022Vitek 2 Gram Negative Ertapenem
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 14, 2004 as substantially equivalent to K032788 (bioMerieux, Inc., 2003) after a 53-day review. Its family tree reaches back 1 generation to 2003. 1 of the 31 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it. It has been recalled once.
- Decided
- Sep 14, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- LON
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032788 (2003). 29 later devices descend from it, 3 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- This deviceK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004
- Descendant · cites it directly · 26 of its ownK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- Descendant · 2 generations on · 22 of its ownK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- Descendant · 3 generations on · 21 of its ownK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- Descendant · 4 generations on · 19 of its ownK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- Descendant · 5 generations on · 15 of its ownK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161217 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64…6 generations on · 2017
Most influential descendants
Showing 5 of 29 · See all- K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007 · cites it directly26descendants
- K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009 · 2 generations on22descendants
- K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009 · 3 generations on21descendants
- K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011 · 4 generations on19descendants
- K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| 0 (this device) | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | — |
| +1 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| +2 | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| +3 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| +4 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| +5 | K121546 | Vitek 2 Gram Negative Doxycycline | bioMerieux, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K032788 | Vitek 2 Gram Negative GatifloxacinSummary page 1…TEK 2 AST-GN Ertapenem C. Predicate Device: VITEK 2 Gram Negative Susceptibility Test for Gatifloxacin (K032788) 0. 510(k) Summary: VITEK® 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia c… | 2003 |
What descends from it? (29)
See all 293 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0838-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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?
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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. VITEK 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella…
Read the full statement (108 words)
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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. VITEK 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens. 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/K041982 · printed Nov 3, 2026
Cite this page
510(k) Report. “K041982: Vitek 2 Gram Negative Ertapenem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041982
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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