510(k) · Cleared
ClearedThermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific (Oxoid Ltd.) · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Jul 24, 2026 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 24, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- JTN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JTN? 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 JTN device
- #1 K230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)score 5.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JTN
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JTN
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JTN
31in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTN
7in 2025
MAUDE reports naming product code JTN, 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 | 1 | — | 1 | 2 |
| 2008 | 4 | 44 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 15 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 0 | — | 5 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 56 | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 33 | 0 | 0 |
| 2018 | 3 | 27 | 0 | 0 |
| 2019 | 3 | 23 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 4 | 67 | 0 | 4 |
| 2024 | 2 | — | 31 | 5 |
| 2025 | 7 | 87 | 0 | 7 |
| 2026 | 4 | 56 | 1 | — |
What is it indicated for?
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and…
Read the full statement (152 words)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 is intended to determine susceptibility of Enterobacterales and Pseudomonas aeruginosa to cefepime/zidebactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 demonstrated acceptable performance to determine susceptibility to cefepime/zidebactam against the following microorganisms:
Enterobacterales (Citrobacter braakii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
Pseudomonas aeruginosa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K261781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261781: Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261781
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026