510(k) · Cleared
ClearedVITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomérieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Sep 28, 2026 as substantially equivalent to K232201 (bioMerieux, Inc., 2023) after a 215-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Sep 28, 2026
- Review
- 215 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K031865 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK031865 Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc. · 2003
- 4 generations backK053186 Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005
- 3 generations backK063597 Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007
- 2 generations backK112000 Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011
- 1 generation backK232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
- This deviceK260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K031865 | Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae | bioMerieux, Inc. | 2003 | — |
| −4 | K053186 | Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae | bioMerieux, Inc. | 2005 | — |
| −3 | K063597 | Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae | bioMerieux, Inc. | 2007 | — |
| −2 | K112000 | Vitek 2 Streptococcus Penicillin | bioMerieux, Inc. | 2011 | — |
| −1 | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2… | bioMerieux, Inc. | 2023 | — |
| 0 (this device) | K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) | Biomérieux, Inc. | 2026 | — |
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 K232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 -…score 13.1 · 4 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 |
|---|---|---|---|
| * | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…Summary page 5…t Code LON, LTT, LTW Common Name: VITEK® 2 AST-ST Cefepime C. Predicate Device: VITEK® 2 AST-ST Penicillin (K232201) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K232201.
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. 2026, 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 AST-Streptococcus Cefepime (≤ 0.06 - ≥4 µg/mL) is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST-Streptococcus Cefepime (≤ 0.06 - ≥4 µg/mL) is a quantitative test. Testing is indicated for Streptococcus pneumoniae (non-meningitis), Streptococcus spp. β-Hemolytic Group…
Read the full statement (193 words)
VITEK 2 AST-Streptococcus Cefepime (≤ 0.06 - ≥4 µg/mL) is designed for antimicrobial susceptibility testing of
Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in
vitro susceptibility to antimicrobial agents.
VITEK 2 AST-Streptococcus Cefepime (≤ 0.06 - ≥4 µg/mL) is a quantitative test. Testing is indicated for Streptococcus
pneumoniae (non-meningitis), Streptococcus spp. β-Hemolytic Group and Streptococcus spp. Viridans Group, as
recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
VITEK 2 AST-Streptococcus Cefepime (≤ 0.06 - ≥4 µg/mL) has demonstrated acceptable performance with the following
organisms:
Streptococcus pneumoniae (non-meningitis)
Streptococcus spp. β-Hemolytic Group (Streptococcus agalactiae, Streptococcus canis, Streptococcus dysgalactiae ssp.
equisimilis, Streptococcus equisimilis ssp. zooepidemicus, Streptococcus pyogenes)
Streptococcus spp. Viridans Group (Streptococcus cristatus, Streptococcus gallolyticus ssp. gallolyticus, Streptococcus
gordonii, Streptococcus infantarius ssp. infantarius, Streptococcus mitis, Streptococcus oralis, Streptococcus
parasanguinis, Streptococcus salivarius ssp. salivarius, Streptococcus sanguinis, Streptococcus uberis, Streptococcus
vestibularis)
The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as
an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans
Streptococcus to antimicrobial agents when used as instructed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260619: VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260619
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026