Atlas FDA

JTN

330 FDA 510(k) clearances · Product code

54 daysmedian time to decision
111 days90th percentile
330clearances measured

FDA profile

Official device name
Susceptibility Test Discs, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1620
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 (K261781)Thermo Fisher Scientific (Oxoid Ltd.)2026-07-24
Gepotidacin GEP 10 µg (K261853)Liofilchem, Inc.2026-07-23
HardyDisk AST Gepotidacin 10µg (GEP10) (K260842)Hardy Diagnostics2026-05-11
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (K251337)Thermo Fisher Scientific (Oxoid Ltd.)2025-12-05
HardyDisk AST Cefiderocol 30µg (FDC30) (K253105)Hardy Diagnostics2025-11-20
Sulopenem SPM 2 µg (K251879)Liofilchem2025-08-12
HardyDisk AST Gepotidacin 10µg (GEP10) (K250956)Hardy Diagnostics2025-06-26
Ceftobiprole BPR 5 µg Disc (K250885)Liofilchem, Inc.2025-06-23
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (K250789)Thermo Fisher Scientific (Oxoid Ltd.)2025-06-12
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (K250454)Hardy Diagnostics2025-05-15
HardyDisk AST Cefiderocol 30µg (FDC30) (K241060)Hardy Diagnostics2024-07-18
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (K231806)Oxoid Limited (Part of Thermo Fisher Scientific)2024-03-22
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 (K232276)Oxoid Limited (Part of Thermo Fisher Scientific)2023-10-06
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (K231568)Hardy Diagnostics2023-07-06
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) (K230651)Becton, Dickinson and Company2023-06-07
HardyDisk AST Rezafungin 5µg (RZF5) (K230827)Hardy Diagnostics2023-06-01
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826)Becton, Dickinson and Company2022-12-21
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (K203336)Oxoid Limited (Part of Thermo Fisher Scientific)2022-09-15
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873)Oxoid Limited (Part of Thermo Fisher Scientific)2021-10-27
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 (K203700)Oxoid Limited (Part of Thermo Fisher Scientific)2021-07-30
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 (K193508)Oxoid Limited (Part of Thermo Fisher Scientific)2020-12-04
HardyDisk AST Cefiderocol 30ug (FDC30) (K193504)Hardy Diagnostics2020-01-23
HardyDisk AST Lefamulin 20µg (LMU20) (K192326)Hardy Diagnostics2019-09-19
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) (K191931)Hardy Diagnostics2019-07-31
HardyDisk AST Omadacycline 30µg (OMC30) (K183298)Hardy Diagnostics2019-01-18
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 (K181975)Oxoid Limited (Part of Thermo Fisher Scientific)2018-09-27
HardyDisk AST Eravacycline 20µg (ERV20) (K182357)Hardy Diagnostics2018-09-26
HardyDisk AST Plazomicin 30ug (PLZ30) (K181700)Hardy Diagnostics2018-07-10
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) (K172621)Hardy Diagnostics2017-10-03
HardyDisk AST Delafloxacin 5 µg (DLX5) (K171975)Hardy Diagnostics2017-08-01
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 (K170127)Hardy Diagnostics2017-03-14
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 (K152846)Hardy Diagnostics2015-11-24
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 (K152838)Hardy Diagnostics2015-11-24
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks (K152516)Becton, Dickinson and Company2015-10-13
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (K112586)Becton, Dickinson and Company (BD)2011-10-18
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 (K103538)Hardy Diagnostics2010-12-17
TELAVANCIN 30 UG, BBL SENSI-DISC (K100722)Becton, Dickinson and Company2010-03-29
HARDYDISK AST TELAVANCIN,30UG (K093807)Hardy Diagnostics2010-01-08
FLUCONAZOLE 25UG BBL SENSI-DISC (K082271)Becton, Dickinson & CO2008-10-06
VORICONAZOLE 1UG BBL SENSI-DISC (K082272)Becton, Dickinson & CO2008-10-02
DORIPENEM 10UG BBL SENSI-DISC (K080998)Becton, Dickinson & CO2008-05-12
HARDYDISK AST DORIPENEM 10 UG (K080019)Hardy Diagnostics2008-01-29
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K070262)Oxoid , Ltd.2007-03-14
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 (K062245)Hardy Diagnostics2006-08-23
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K060286)Oxoid , Ltd.2006-03-17
TIGECYCLINE 15UG BBL SENSI-DISC (K052853)Becton, Dickinson & CO2005-11-17
TELITHROMYCIN 15UG BBL SENSI-DISC (K052876)Becton, Dickinson & CO2005-11-14
GEMIFLOXACIN, 5UG BBL SENSI-DISC (K050062)Becton, Dickinson & CO2005-02-10
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K042157)Oxoid , Ltd.2004-09-14
ERTAPENEM 10UG BBL SENSI-DISC (K020842)Becton, Dickinson & CO2002-05-15
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 (K011384)Hardy Diagnostics2001-06-13
HARDKYDISK NEOMYCIN, 30 MCG (K011385)Hardy Diagnostics2001-05-18
HARDYDISK BACITRACIN, 10MCG, MODEL Z927 (K011086)Hardy Diagnostics2001-04-26
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010536)Oxoid , Ltd.2001-04-24
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010537)Oxoid , Ltd.2001-04-24
HARDYDISK SULFISOXAZOLE (K003690)Hardy Diagnostics2001-01-25
HARDYDISK TRIMETHOPRIM 5MCG (K003554)Hardy Diagnostics2001-01-19
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG (K003556)Hardy Diagnostics2001-01-17
HARDYDISK NAFCILLIN, 1 MCG (K003536)Hardy Diagnostics2001-01-12
HARDYDISK RIFAMPIN, 5MCG (K003537)Hardy Diagnostics2001-01-12
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG (K003686)Hardy Diagnostics2001-01-12
HARDY DISK, CEFPODOXINE, 10MCG (K003532)Hardy Diagnostics2000-12-13
HARDYDISK CLINDAMYCIN, 2MCG (K002662)Hardy Diagnostics2000-11-02
HARDYDISK GENTAMICIN, 120MCG (K002369)Hardy Diagnostics2000-10-26
HARDYDISK LEVOFLOXACIN, 5MCG (K002664)Hardy Diagnostics2000-10-26
HARDY DISK CEFTIZOXIME, 30MCG (K002367)Hardy Diagnostics2000-10-26
HARDYDISK CEFOTETAN, 30MCG (K002661)Hardy Diagnostics2000-10-26
HARDYDISK LOMEFLOXACIN, 10MCG (K002660)Hardy Diagnostics2000-10-26
HARDYDISK CEFUROXIME, 30MCG (K002656)Hardy Diagnostics2000-10-25
HARDYDISK STREPTOMYCIN, 300MCG (K002368)Hardy Diagnostics2000-10-25
HARDYDISK NETILMICIN, 30MCG (K002663)Hardy Diagnostics2000-10-19
LINEZOLID, 30UG, BBL SENSI-DISC (K002165)Dickinson, and Co.2000-09-05
HARDY DISK CLARITHROMYCIN, 15MCG (K001728)Hardy Diagnostics2000-07-27
HARDYDISK CINOXACIN, 100 MCG (K001487)Hardy Diagnostics2000-06-07
HARDYDISK CEFOPERAZONE, 75 MCG (K001489)Hardy Diagnostics2000-06-01
HARDYDISK CEFONICID, 30 MCG (K001490)Hardy Diagnostics2000-06-01
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000930)Oxoid , Ltd.2000-05-22
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000928)Oxoid , Ltd.2000-05-15
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (K000762)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-04-25
HARDYDISK, CEPHALOTHIN 30MCG (K000526)Hardy Diagnostics2000-04-13
GATIFLOXACIN, 5 UG, BBL SENSI-DISC (K000829)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-04-13
HARDYDISK, AMPICILLIN, 10MCG (K000268)Hardy Diagnostics2000-04-07
HARDYDISK CEFTRIAXONE 30MCG (K000440)Hardy Diagnostics2000-04-07
HARDYDISK OFLOXACIN 5MCG (K000525)Hardy Diagnostics2000-04-07
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG (K000261)Hardy Diagnostics2000-04-07
HARDYDISK, VANCOMYCIN 30MCG (K000509)Hardy Diagnostics2000-04-07
HARDYDISK, CEFOTAXIME 30MCG (K000524)Hardy Diagnostics2000-04-07
HARDYDISK, NITROFURANTOIN (K000272)Hardy Diagnostics2000-04-07
HARDYDISK, SULFA/TRIMETH (K000271)Hardy Diagnostics2000-04-07
HARDYDISK, CEFOXITIN, 30MCG (K000305)Hardy Diagnostics2000-03-31
HARDYDISK, TETRACYCLINE 30MCG (K000304)Hardy Diagnostics2000-03-29
HARDY DISK, PENICILLIN, 10 UNITS (K000302)Hardy Diagnostics2000-03-24
HARDYDISK, CIPROFLOXACIN, 5MCG (K000258)Hardy Diagnostics2000-03-21
HARDYDISK, KANAMYCIN, 30MCG (K000203)Hardy Diagnostics2000-03-21
HARDYDISK, CEFTAZIDIME, 30MCG (K000259)Hardy Diagnostics2000-03-21
HARDYDISK, CARBENICILLIN, 100MCG (K000181)Hardy Diagnostics2000-03-02
HARDYDISK TICARILLIN 75MCG (K000175)Hardy Diagnostics2000-03-02
HARDYDISK, NALIDIXIC ACID, 30MCG (K000130)Hardy Diagnostics2000-02-29
HARDYDISK, STREPTOMYCIN 10MCG (K000201)Hardy Diagnostics2000-02-29
HARDYDISK TOBRAMYCIN, 10MCG (K000182)Hardy Diagnostics2000-02-29
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