LON · Class II · 21 CFR 866.1645

FDA Product Code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Under FDA product code LON, automated antimicrobial susceptibility testing systems are cleared for use in clinical microbiology laboratories.

Unlike manual methods, LON systems automatically inoculate, incubate, and read antimicrobial susceptibility panels, delivering results in hours rather than days. They are essential in high-volume laboratories requiring rapid, standardized antibiotic susceptibility data.

LON devices are Class II medical devices, regulated under 21 CFR 866.1645 and reviewed by the FDA Microbiology panel.

Leading manufacturers include bioMerieux, Inc., Becton, Dickinson and Company and BIOMERIEUX.

289
Total
289
Cleared
90d
Avg days
1986
Since
Declining activity - 7 submissions in the last 2 years vs 18 in the prior period
Review times increasing: avg 122d recently vs 89d historically

FDA 510(k) Cleared System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Devices (Product Code LON)

289 devices
1–24 of 289
Cleared Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282
bioMerieux, Inc.
Microbiology · 76d
Cleared Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281
BIOMERIEUX
Microbiology · 56d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 08, 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713
Becton, Dickinson and Company
Microbiology · 66d
Cleared May 19, 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
K250447
Becton, Dickinson and Company
Microbiology · 90d
Cleared Mar 14, 2025
VITEK COMPACT PRO
K234012
bioMerieux, Inc.
Microbiology · 451d
Cleared Mar 06, 2025
BD Phoenix™ Automated Microbiology System
K250344
Becton, Dickinson and Company
Microbiology · 28d
Cleared Mar 15, 2024
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
K233986
Becton, Dickinson and Company
Microbiology · 88d
Cleared Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000
bioMerieux, Inc.
Microbiology · 84d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
K232201
bioMerieux, Inc.
Microbiology · 90d
Cleared Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
K230864
bioMerieux, Inc.
Microbiology · 98d
Cleared Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378
bioMerieux, Inc.
Microbiology · 325d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073
bioMerieux, Inc.
Microbiology · 210d
Cleared Feb 03, 2023
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
K223481
bioMerieux, Inc.
Microbiology · 77d
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
K220803
bioMerieux, Inc.
Microbiology · 315d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805
bioMerieux, Inc.
Microbiology · 209d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243
bioMerieux, Inc.
Microbiology · 385d
Cleared Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
K213899
bioMerieux, Inc.
Microbiology · 210d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931
bioMerieux, Inc.
Microbiology · 169d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023
bioMerieux, Inc.
Microbiology · 113d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
K213241
bioMerieux, Inc.
Microbiology · 148d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287
bioMerieux, Inc.
Microbiology · 268d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396
bioMerieux, Inc.
Microbiology · 389d

About Product Code LON - Regulatory Context

510(k) Submission Activity

289 total 510(k) submissions under product code LON since 1986, with 289 receiving FDA clearance (average review time: 90 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 18 in the prior period.

FDA Review Time

Recent submissions under LON have taken an average of 122 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.

LON devices are reviewed by the Microbiology panel. Browse all Microbiology devices →