510(k) · Cleared
ClearedHardyDisk AST Cefiderocol 30ug (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 Jan 23, 2020 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 23, 2020
- Review
- 36 days
- Class
- Class II
- Product code
- JTN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK193504 HardyDisk AST Cefiderocol 30ug (FDC30)Hardy Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK221826 BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)Becton, Dickinson and Company · 2022
Most influential descendants
Showing 1 of 1 · See all- K221826BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)Becton, Dickinson and Company · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Hardy Diagnostics | 2020 | — |
| +1 | K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | 2022 | 0 |
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, K221826 (Becton, Dickinson and Company, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 | — |
https://510kreport.com/device/K193504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193504: HardyDisk AST Cefiderocol 30ug (FDC30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193504
Report an extraction error
Are you the manufacturer?
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