Cleared Traditional

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903) - FDA 510(k) Clearance

Class I Microbiology device.

K123903 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
145d
Days
Class 1
Risk

K123903 is an FDA 510(k) clearance for the BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic). 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 May 13, 2013 after a review of 145 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 K123903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date May 13, 2013
Days to Decision 145 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
43d slower than avg
Panel avg: 102d · This submission: 145d
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

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 K123903.
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · bioMerieux, Inc. · Mar 2017
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · Becton, Dickinson and Company · Feb 2016
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · Becton, Dickinson and Company · Dec 2014
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · bioMerieux, Inc. · Jan 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · bioMerieux, Inc. · Jan 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · bioMerieux, Inc. · Jan 2013