Cleared Special

BD BACTEC Plus Aerobic/F Culture Vials (K083572) - FDA 510(k) Clearance

Class I Microbiology device.

K083572 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
21d
Days
Class 1
Risk

K083572 is an FDA 510(k) clearance for the BD BACTEC Plus Aerobic/F Culture Vials. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on December 24, 2008 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson & CO devices

Submission Details

510(k) Number K083572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date December 24, 2008
Days to Decision 21 days
Submission Type Special
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
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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

Becton, Dickinson and Company
Katherine Cicala

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 47
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K083572.
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 (plastic)
K113558 · Becton, Dickinson and Company · Mar 2012
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · bioMerieux, Inc. · Jul 2003
BACT/ALERT SN CULTURE BOTTLE
K021123 · bioMerieux, Inc. · Apr 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · bioMerieux, Inc. · Apr 2002