Cleared Traditional

BD BACTEC FXI Culture System (K260213) - FDA 510(k) Clearance

Class I Microbiology device.

K260213 · Bd Diagnostic Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
125d
Days
Class 1
Risk

K260213 is an FDA 510(k) clearance for the BD BACTEC FXI Culture System. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Bd Diagnostic Systems (Sparks, US). The FDA issued a Cleared decision on May 28, 2026 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Diagnostic Systems devices

Submission Details

510(k) Number K260213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2026
Decision Date May 28, 2026
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 102d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Bd Diagnostic Systems
Susan Kircher

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MDB System, Blood Culturing

All 67
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