Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JTN — Predicate Candidate Screening
330 FDA 510(k) clearances under this product code; the 50 most recent screened below.
54 daysmedian FDA review time
111 days90th percentile
330clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 | 56 | 0 |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | 2026-07-23 | 50 | 0 |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2026-05-11 | 56 | 0 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 | 219 | 0 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2025-11-20 | 57 | 1 |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | 2025-08-12 | 55 | 0 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2025-06-26 | 87 | 0 |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | 2025-06-23 | 90 | 0 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 | 90 | 0 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | 2025-05-15 | 86 | 0 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2024-07-18 | 91 | 0 |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 | 276 | 0 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 | 67 | 0 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | 2023-07-06 | 36 | 0 |
| K230651 | BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | 2023-06-07 | 90 | 0 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | 2023-06-01 | 66 | 0 |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | 2022-12-21 | 181 | 0 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 | 672 | 0 |
| K210873 | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 | 217 | 0 |
| K203700 | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 | 224 | 0 |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2020-12-04 | 352 | 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 |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | Hardy Diagnostics | 2019-01-18 | 52 | 0 |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) ME | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 | 65 | 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 |
| 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 |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | Hardy Diagnostics | 2017-03-14 | 60 | 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 |
| K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicro | Becton, Dickinson and Company | 2015-10-13 | 40 | 0 |
| K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | Becton, Dickinson and Company (BD) | 2011-10-18 | 42 | 1 |
| K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | Hardy Diagnostics | 2010-12-17 | 15 | 0 |
| K100722 | TELAVANCIN 30 UG, BBL SENSI-DISC | Becton, Dickinson and Company | 2010-03-29 | 14 | 0 |
| K093807 | HARDYDISK AST TELAVANCIN,30UG | Hardy Diagnostics | 2010-01-08 | 28 | 0 |
| K082271 | FLUCONAZOLE 25UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-10-06 | 56 | 0 |
| K082272 | VORICONAZOLE 1UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-10-02 | 52 | 0 |
| K080998 | DORIPENEM 10UG BBL SENSI-DISC | Becton, Dickinson & CO | 2008-05-12 | 35 | 1 |
| K080019 | HARDYDISK AST DORIPENEM 10 UG | Hardy Diagnostics | 2008-01-29 | 26 | 0 |
| K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2007-03-14 | 47 | 1 |
| K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | Hardy Diagnostics | 2006-08-23 | 21 | 0 |
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2006-03-17 | 42 | 1 |
| K052853 | TIGECYCLINE 15UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-11-17 | 37 | 0 |
| K052876 | TELITHROMYCIN 15UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-11-14 | 33 | 0 |
| K050062 | GEMIFLOXACIN, 5UG BBL SENSI-DISC | Becton, Dickinson & CO | 2005-02-10 | 30 | 0 |
| K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 2004-09-14 | 35 | 0 |
| K020842 | ERTAPENEM 10UG BBL SENSI-DISC | Becton, Dickinson & CO | 2002-05-15 | 61 | 1 |
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