510(k) · Cleared
ClearedHardyDisk AST Delafloxacin 5 µg (DLX5)
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 Aug 1, 2017 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 1, 2017
- Review
- 32 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. 2017, 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?
Use of HardyDisk™ AST Delafloxacin 5ug (DLX5), for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin. The concentration of Delafloxacin 5pug (DLXS5), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive…
Read the full statement (181 words)
Use of HardyDisk™ AST Delafloxacin 5ug (DLX5), for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.
The concentration of Delafloxacin 5pug (DLXS5), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections:
Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains)
Staphylococcus haemolyticus
Streptococcus pyogenes
Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus)
Enterococcus faecalis
Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae
Pseudomonas aeruginosa
The concentration of Delafloxacin Spg (DLXS5), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use:
Streptococcus dysgalactiae
Enterobacter aerogenes
Haemophilus parainfluenzae
Klebsiella oxytoca
Proteus mirabilis
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 Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171975: HardyDisk AST Delafloxacin 5 µg (DLX5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171975
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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