Medical device manufacturer
Hardy Diagnostics
Hardy Diagnostics holds 109 FDA 510(k) clearances across 8 product codes. Median elapsed review time is 57 days. openFDA lists 20 recall records naming the company. FDA publishes it under 5 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 109
- Product codes
- 8
- Median review
- 57 days
- Recall records
- 20
How does FDA spell Hardy Diagnostics?
FDA publishes this company under 5 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| HARDY DIAGNOSTICS | device/registrationlisting | normalised |
| Hardy Diagnostics | device/recall | normalised |
| Hardy Diagnostics | device/registrationlisting | normalised |
| Hardy Diagnostics | device/510k | normalised |
| Hardy Diagnostics | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Hardy Diagnostics file in?
8 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 83 | 53 days | |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 10 | 71 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 5 | 182 days | |
| JSM | Culture Media, Non-Propagating Transport | 3 | 236 days | |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 109 days | |
| PQZ | Gbs Culture Media, Selective And Differential | 3 | 89 days | |
| JXC | Kit, Screening, Yeast | 1 | 204 days | |
| LKS | Device, Parasite Concentration | 1 | 71 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Hardy Diagnostics had a recall?
openFDA lists 20 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2887-2026Open, ClassifiedJTN
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Z-2041-2025Class IIOpen, ClassifiedJSO
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Z-1835-2021Class IITerminatedKPA
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
Z-0919-2021Class IITerminatedJSO
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Z-0655-2021Class IITerminatedJSM
There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
Showing the 5 most recently initiated of 20.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Hardy Diagnostics cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 56 | |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 57 | |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 87 | |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | JTN | 86 | |
| K233534 | Viral Transport Medium | JSM | 273 | |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 91 | |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | JTN | 36 | |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | JTN | 66 | |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | JTN | 36 | |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | JTN | 23 |
Source: openFDA device/510k · retrieved
Where is Hardy Diagnostics registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Hardy Diagnostics files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.