Cleared Traditional

K151866 - BD BACTEC Peds Plus/F Culture Vials (pl...

K151866 is an FDA 510(k) clearance for BD BACTEC Peds Plus/F Culture Vials (pl..., 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 231-day FDA review.

K151866 · Becton, Dickinson and Company · Microbiology device
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Feb 2016
Decision
231d
Days
Class 1
Risk

K151866 is an FDA 510(k) clearance for the BD BACTEC Peds Plus/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 February 25, 2016 after a review of 231 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

FDA 510(k) Submission Details - K151866

510(k) Number K151866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2015
Decision Date February 25, 2016
Days to Decision 231 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
129d slower than avg
Panel avg: 102d · This submission: 231d
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 K151866.
BacT/ALERT FA Plus
K183166 · bioMerieux, Inc. · Feb 2019
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 PLUS ANAEROBIC/F (PLASTIC)
K141810 · Becton, Dickinson and Company · Dec 2014
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