Cleared Traditional

K222559 - BD BACTEC™ Myco/F Lytic Culture Vials (FDA 510(k) Clearance)

Class I Microbiology device.

K222559 · Becton, Dickinson and Company · Microbiology device
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Mar 2023
Decision
212d
Days
Class 1
Risk

K222559 is an FDA 510(k) clearance for the BD BACTEC™ Myco/F Lytic Culture Vials. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 24, 2023 after a review of 212 days - an extended review cycle.

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.

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Submission Details

510(k) Number K222559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2022
Decision Date March 24, 2023
Days to Decision 212 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
110d slower than avg
Panel avg: 102d · This submission: 212d
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.