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510(k) K260213

BD BACTEC FXI Culture System by BD Diagnostic Systems — Product Code MDB

K260213 is an FDA 510(k) premarket notification submitted by BD Diagnostic Systems for the device "BD BACTEC FXI Culture System". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. BD Diagnostic Systems has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
January 23, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by BD Diagnostic Systems

  • K032518 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (September 15, 2003)
  • K032153 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (September 11, 2003)
  • K032259 — PASCO MIC AND MIC/ID PANELS (August 19, 2003)
  • K031429 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (June 6, 2003)
  • K030091 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (February 28, 2003)

Other clearances for product code MDB

  • K222559 — BD BACTEC™ Myco/F Lytic Culture Vials (March 24, 2023)
  • K222591 — BD BACTEC™ Plus Aerobic/F Culture Vials (March 24, 2023)
  • K190405 — BACT/ALERT MP Reagent System (May 15, 2019)
  • K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus (February 11, 2019)
  • K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a (March 16, 2018)
  • K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (March 28, 2017)
  • K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P (February 9, 2017)
  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic) (February 25, 2016)
  • K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (December 10, 2014)

FDA data resources