510(k) · Cleared
ClearedVITEK 2 AST-Gram Positive Cefoxitin Screen
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 Oct 13, 2022 as substantially equivalent to K053097 (bioMerieux, Inc., 2005) after a 209-day review. Its family tree reaches back 1 generation to 2005. 1 of the 2 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 13, 2022
- Review
- 209 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053097 (2005). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK053097 Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · Recalled (Class I)
- This deviceK220805 VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2022
Class I recalls in this family
- K053097 Vitek 2 Gram Positive Cefoxitin Screendirect predicate · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053097 | Vitek 2 Gram Positive Cefoxitin Screen | bioMerieux, Inc. | 2005 | Class I |
| 0 (this device) | K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | bioMerieux, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K053097 | Vitek 2 Gram Positive Cefoxitin ScreenSummary page 4…LON, LTW, LTT Common Name: VITEK® 2 AST-GP Cefoxitin Screen C. Predicate Device: VITEK® 2 Gram Positive Cefoxitin Screen (K053097) D. Device Description: VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphyloc… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K053097Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 1 other device also cites its predicate K053097.
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. 2022, 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-Gram Positive Cefoxitin Screen test is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. 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 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220805: VITEK 2 AST-Gram Positive Cefoxitin Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220805
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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