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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Blood Culturing
510(k) Number K260213
Device Name BD BACTEC FXI Culture System
Applicant
BD Diagnostic Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact Susan Kircher
Correspondent
Bd Diagnostic Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact Susan Kircher
Regulation Number866.2560
Classification Product Code
MDB  
Date Received01/23/2026
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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