Hardy Diagnostics: FDA filings under this applicant name
FDA lists 110 510(k) clearances under the applicant name “Hardy Diagnostics” (first 1993, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Since 2017 the median was 56 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 56 |
| 2016 | 1 | 265 |
| 2017 | 5 | 60 |
| 2018 | 3 | 27 |
| 2019 | 4 | 38 |
| 2020 | 1 | 36 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 51 |
| 2024 | 2 | 182 |
| 2025 | 3 | 86 |
| 2026 | 2 | 57 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hardy Diagnostics took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 84 | 84 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 10 | 10 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 5 | 5 |
| JSM | Culture Media, Non-Propagating Transport | 3 | 3 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 3 |
| PQZ | Gbs Culture Media, Selective And Differential | 3 | 3 |
| JXC | Kit, Screening, Yeast | 1 | 1 |
| LKS | Device, Parasite Concentration | 1 | 1 |
Review panels
- Microbiology (110)
Most recent Hardy Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | JTN | 2026-08-20 | 58 |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 2026-05-11 | 56 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 2025-11-20 | 57 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 2025-06-26 | 87 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | JTN | 2025-05-15 | 86 |
| K233534 | Viral Transport Medium | JSM | 2024-08-02 | 273 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 2024-07-18 | 91 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | JTN | 2023-07-06 | 36 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | JTN | 2023-06-01 | 66 |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | JTN | 2020-01-23 | 36 |
100 earlier clearances. See the full list in Caduvo.
Recalls
20 product recalls in 14 recall events; 2 initiated in the last five years. Most recent: 2026-06-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hardy Media (114 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hardy Diagnostics?
FDA lists 110 510(k) clearances under the applicant name “Hardy Diagnostics” (first 1993, latest 2026), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hardy Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hardy Diagnostics is 57 days. Since 2017: 56 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hardy Diagnostics?
The most frequent FDA product codes under this applicant name are JTN (Susceptibility Test Discs, Antimicrobial, 84); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 10); JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, 5).
Next steps
- See all 110 Hardy Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JTN, Hardy Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.