Cleared Traditional

K113558 - BD BACTEC Plus Aerobic/F Culture Vials ...

K113558 is an FDA 510(k) clearance for BD BACTEC Plus Aerobic/F Culture Vials ..., manufactured by Becton, Dickinson and Company. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K113558 · Becton, Dickinson and Company · Microbiology device
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Mar 2012
Decision
106d
Days
Class 1
Risk

K113558 is an FDA 510(k) clearance for the BD BACTEC Plus Aerobic/F Culture Vials (plastic). 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 16, 2012 after a review of 106 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K113558

510(k) Number K113558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date March 16, 2012
Days to Decision 106 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
4d slower than avg
Panel avg: 102d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MDB Device Classification - Class 1, General Controls

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 Peers - MDB System, Blood Culturing

All 56
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K113558.
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · bioMerieux, Inc. · Jan 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · bioMerieux, Inc. · Jan 2013
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · Becton, Dickinson and Company · Aug 2012
BD BACTEC Plus Aerobic/F Culture Vials
K083572 · Becton, Dickinson & CO · Dec 2008
VERSATREK
K032306 · Trek Diagnostic Systems, Inc. · Aug 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · bioMerieux, Inc. · Jul 2003