Cleared Traditional

K120994 - BD BACTEC Plus PRIME Aerobic/F Culture Vials (FDA 510(k) Clearance)

Class I Microbiology device.

K120994 · Becton, Dickinson and Company · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
127d
Days
Class 1
Risk

K120994 is an FDA 510(k) clearance for the BD BACTEC Plus PRIME Aerobic/F 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 August 7, 2012 after a review of 127 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.

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Submission Details

510(k) Number K120994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date August 07, 2012
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 102d · This submission: 127d
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.