BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)— 510(k) K131331
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K131331 for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML), Substantially Equivalent on 2013-07-10. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code LON
view all- 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)
More clearances from Becton, Dickinson & CO
view all- K160164 — BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- K160161 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K141474 — BECTON DICKINSON INTELLIPORT SYSTEM
- K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
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 →
Recalls naming K131331
K-number listed on FDA's recall record- Z-0239-2026 — BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
- Z-0592-2025 — BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
- Z-3246-2024 — BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624
- Z-3247-2024 — BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131331.
Data sourced from openFDA. This site is unofficial and independent of the FDA.