Cleared Traditional

BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810) - FDA 510(k) Clearance

Class I Microbiology device.

K141810 · Becton, Dickinson and Company · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
156d
Days
Class 1
Risk

K141810 is an FDA 510(k) clearance for the BD BACTEC PLUS ANAEROBIC/F (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 December 10, 2014 after a review of 156 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.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K141810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date December 10, 2014
Days to Decision 156 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
54d slower than avg
Panel avg: 102d · This submission: 156d
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 Peers - MDB System, Blood Culturing

All 47
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K141810.
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
K173873 · Becton, Dickinson and Company · Mar 2018
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
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903 · Becton, Dickinson & CO · May 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · bioMerieux, Inc. · Jan 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · bioMerieux, Inc. · Jan 2013