Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hardy Diagnostics — Predicate Candidate Screening
109 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
91 days90th percentile
109clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2026-05-11 | 56 | 0 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2025-11-20 | 57 | 1 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2025-06-26 | 87 | 0 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | 2025-05-15 | 86 | 0 |
| K233534 | Viral Transport Medium | Hardy Diagnostics | 2024-08-02 | 273 | 0 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2024-07-18 | 91 | 0 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | 2023-07-06 | 36 | 0 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | 2023-06-01 | 66 | 0 |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Hardy Diagnostics | 2020-01-23 | 36 | 0 |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Hardy Diagnostics | 2019-09-19 | 23 | 0 |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Hardy Diagnostics | 2019-07-31 | 12 | 0 |
| K190553 | HardyCHROM CRE | Hardy Diagnostics | 2019-04-29 | 55 | 1 |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | Hardy Diagnostics | 2019-01-18 | 52 | 0 |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | Hardy Diagnostics | 2018-09-26 | 27 | 0 |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | Hardy Diagnostics | 2018-07-10 | 13 | 0 |
| K173903 | Granada Medium | Hardy Diagnostics | 2018-03-22 | 90 | 0 |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | Hardy Diagnostics | 2017-10-03 | 33 | 0 |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | Hardy Diagnostics | 2017-08-01 | 32 | 0 |
| K170586 | Strep B Carrot Broth One-Step | Hardy Diagnostics | 2017-05-22 | 83 | 0 |
| K170481 | Strep B Carrot Broth Kit | Hardy Diagnostics | 2017-05-16 | 89 | 0 |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | Hardy Diagnostics | 2017-03-14 | 60 | 0 |
| K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016-11-15 | 265 | 0 |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | Hardy Diagnostics | 2015-11-24 | 56 | 0 |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | Hardy Diagnostics | 2015-11-24 | 56 | 0 |
| K102922 | HARDYCHROM MRSA | Hardy Diagnostics | 2011-05-04 | 215 | 2 |
| K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | Hardy Diagnostics | 2010-12-17 | 15 | 0 |
| K093807 | HARDYDISK AST TELAVANCIN,30UG | Hardy Diagnostics | 2010-01-08 | 28 | 0 |
| K080019 | HARDYDISK AST DORIPENEM 10 UG | Hardy Diagnostics | 2008-01-29 | 26 | 0 |
| K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | Hardy Diagnostics | 2006-08-23 | 21 | 0 |
| K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | Hardy Diagnostics | 2001-06-13 | 37 | 0 |
| K011385 | HARDKYDISK NEOMYCIN, 30 MCG | Hardy Diagnostics | 2001-05-18 | 11 | 0 |
| K011086 | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 | Hardy Diagnostics | 2001-04-26 | 16 | 0 |
| K003690 | HARDYDISK SULFISOXAZOLE | Hardy Diagnostics | 2001-01-25 | 56 | 0 |
| K003554 | HARDYDISK TRIMETHOPRIM 5MCG | Hardy Diagnostics | 2001-01-19 | 63 | 0 |
| K003556 | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG | Hardy Diagnostics | 2001-01-17 | 61 | 0 |
| K003536 | HARDYDISK NAFCILLIN, 1 MCG | Hardy Diagnostics | 2001-01-12 | 57 | 0 |
| K003537 | HARDYDISK RIFAMPIN, 5MCG | Hardy Diagnostics | 2001-01-12 | 57 | 0 |
| K003686 | HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG | Hardy Diagnostics | 2001-01-12 | 43 | 0 |
| K003532 | HARDY DISK, CEFPODOXINE, 10MCG | Hardy Diagnostics | 2000-12-13 | 27 | 0 |
| K002662 | HARDYDISK CLINDAMYCIN, 2MCG | Hardy Diagnostics | 2000-11-02 | 69 | 0 |
| K002369 | HARDYDISK GENTAMICIN, 120MCG | Hardy Diagnostics | 2000-10-26 | 84 | 0 |
| K002664 | HARDYDISK LEVOFLOXACIN, 5MCG | Hardy Diagnostics | 2000-10-26 | 62 | 0 |
| K002367 | HARDY DISK CEFTIZOXIME, 30MCG | Hardy Diagnostics | 2000-10-26 | 84 | 0 |
| K002661 | HARDYDISK CEFOTETAN, 30MCG | Hardy Diagnostics | 2000-10-26 | 62 | 0 |
| K002660 | HARDYDISK LOMEFLOXACIN, 10MCG | Hardy Diagnostics | 2000-10-26 | 62 | 0 |
| K002656 | HARDYDISK CEFUROXIME, 30MCG | Hardy Diagnostics | 2000-10-25 | 61 | 0 |
| K002368 | HARDYDISK STREPTOMYCIN, 300MCG | Hardy Diagnostics | 2000-10-25 | 83 | 0 |
| K002663 | HARDYDISK NETILMICIN, 30MCG | Hardy Diagnostics | 2000-10-19 | 55 | 0 |
| K001728 | HARDY DISK CLARITHROMYCIN, 15MCG | Hardy Diagnostics | 2000-07-27 | 50 | 0 |
| K001487 | HARDYDISK CINOXACIN, 100 MCG | Hardy Diagnostics | 2000-06-07 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda