BD BACTEC FXI Culture System— 510(k) K260213
Substantially EquivalentBD Diagnostic Systems
FDA 510(k) clearance K260213 for BD BACTEC FXI Culture System, Substantially Equivalent on 2026-05-28. Applicant: BD Diagnostic Systems. Device class: 1.
Summary
The BD BACTEC FXI Culture System comes from BD Diagnostic Systems and is filed under MDB, blood culturing systems.
Class I, 21 CFR 866.2560. Microbiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
BD Diagnostic Systems filed from Sparks, Maryland. Review took 125 calendar days (January 23 to May 28, 2026).
Clearance details
- Applicant
- BD Diagnostic Systems
- Product code
- Product code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code MDB
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view all- K032518 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
- K032153 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
- K032259 — PASCO MIC AND MIC/ID PANELS
- K031429 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
- K030091 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
Adverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.