510(k) · Cleared
ClearedHardyDisk AST Cefiderocol 30µg (FDC30)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hardy Diagnostics · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Jul 18, 2024 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 18, 2024
- Review
- 91 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. 2024, 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?
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp.…
Read the full statement (162 words)
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk™ AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Cefiderocol.
HardyDisk™ AST Cefiderocol at concentration 30µg can be used to determine the zone diameter (mm) of Cefiderocol against the following microorganisms.
Active both in vitro and clinical infections against:
Gram-negative bacteria
Escherichia coli
Enterobacter cloacae complex
Proteus mirabilis
Pseudomonas aeruginosa
Acinetobacter baumannii complex
Klebsiella pneumoniae
Serratia marcescens
Active in vitro against:
Gram-negative bacteria
Citrobacter freundii complex
Citrobacter koseri
Klebsiella aerogenes
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Providencia rettgeri
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K241060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241060: HardyDisk AST Cefiderocol 30µg (FDC30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026