Product code LON— Microbiology
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- Classification name
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Total cleared
- 289
- First cleared
- Most recent
Market context for product code LON
FDA has cleared devices under product code LON between 1986 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
Top applicants under product code LON
Adverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LON
1–100 of 289- K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
- K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
- K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
- K234012 — VITEK COMPACT PRO
- K250344 — BD Phoenix Automated Microbiology System
- K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
- K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
- K232756 — Colibrí
- K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
- K230864 — 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
- K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
- K211748 — Selux AST System; Model AST Gen 1.0
- K222430 — VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
- K223478 — VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL)
- K222073 — VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
- K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
- K220803 — 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
- K211759 — Selux AST System; Model AST Gen 1.0
- K220805 — VITEK 2 AST-Gram Positive Cefoxitin Screen
- K220546 — Colibrí System
- K212243 — VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
- K213899 — 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
- K213931 — VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
- K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
- K213241 — 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
- K212849 — VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
- K210287 — VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
- K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
- K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
- K201675 — VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
- K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
- K193299 — VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
- K201405 — LabPro Data Management System
- K200590 — VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
- K193572 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
- K193567 — VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)
- K192110 — Vitek Densichek
- K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
- K190905 — BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL)
- K190616 — VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
- K183524 — VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
- K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
- K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)
- K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
- K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
- K181665 — BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
- K173523 — BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
- K173252 — BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
- K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL
- K172731 — VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
- K162737 — VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
- K163637 — BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
- K163563 — VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)
- K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
- K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
- K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)
- K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
- K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
- K161227 — VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
- K152075 — VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
- K151320 — BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
- K142170 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
- K141149 — VITEK 2 AST GP CEFTAROLINE
- K140468 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
- K132909 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
- K132674 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
- K132507 — VITEK 2 AST ST MEROPENEM
- K131779 — VITEK 2 AST-ST TIGECYCLINE
- K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
- K131331 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
- K123404 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
- K123266 — BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
- K121546 — VITEK 2 GRAM NEGATIVE DOXYCYCLINE
- K121100 — VITEK 2 AST STREPTOCOCUS VANCOMYCIN
- K122547 — GRAM POSTITVE CLINDAMYCIN
- K122359 — VITEK 2 STRPTOCOCCUS CEFTRIAXONE
- K121863 — VITEK 2 AST-ST CEFOTAXIME
- K113783 — VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
- K113200 — VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
- K111893 — VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
- K111976 — VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
- K113305 — VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
- K110106 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
- K112000 — VITEK 2 STREPTOCOCCUS PENICILLIN
- K111909 — VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
- K103752 — VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
- K112228 — VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
- K112129 — VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
- K112075 — VITEK 2 STRPTOCOCCUS AMPICILLIN
- K111599 — VITEK 2 AST-ST LINEZOLID
- K093076 — VITEK 2 GRAM POSITIVE DOXCYCLINE
- K093224 — DENSICHECK PLUS
- K092919 — MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
- K083536 — DENSICHEK PLUS
- K091899 — VITEK 2 GRAM NEGATIVE MEROPENEM
- K091126 — VITEK 2 GRAM POSITIVE DAPTOMYCIN
- K082346 — VITEK 2 GRAM NEGATIVE DORIPENEM
- K083383 — VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
Data sourced from openFDA. This site is unofficial and independent of the FDA.