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510(k) K250447

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) by Becton, Dickinson and Company — Product Code LON

K250447 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)". The FDA issued a decision of Substantially Equivalent on May 19, 2025. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type

Other clearances by Becton, Dickinson and Company

  • K260128 — BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (April 15, 2026)
  • K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillar (April 10, 2026)
  • K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Bloo (April 10, 2026)
  • K260184 — Onclarity™ Self-Collection Kit (April 2, 2026)
  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)

Other clearances for product code LON

  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (March 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (March 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • K232756 — Colibrí (December 27, 2023)
  • K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus (October 23, 2023)

FDA data resources