510(k) · Cleared
ClearedVITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
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 12, 2019 after an 83-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Mar 12, 2019
- Review
- 83 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK183524 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK191766 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK213931 VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK222073 VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK251579 VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK222430 VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2…Biomerieux Sa, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc. · 2019 · cites it directly7descendants
- K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. · 2022 · 2 generations on2descendants
- K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc. · 2023 · 3 generations on1descendant
- K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025 · 4 generations on0descendants
- K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4…Biomerieux Sa, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | bioMerieux, Inc. | 2019 | — |
| +1 | K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | bioMerieux, Inc. | 2019 | — |
| +2 | K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | 2022 | — |
| +3 | K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | 2023 | — |
| +4 | K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | 2025 | — |
| +2 | K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN… | Biomerieux Sa, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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.
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K191766 (bioMerieux, Inc., 2019) has gone furthest, with 7 descendants of its own.
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. 2019, 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 | — |
https://510kreport.com/device/K183524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183524: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183524
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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