Cleared Traditional

BACTEC PEDS PLUS/F (K926304) - FDA 510(k) Clearance

Class I Microbiology device.

K926304 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1993
Decision
79d
Days
Class 1
Risk

K926304 is an FDA 510(k) clearance for the BACTEC PEDS PLUS/F. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K926304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date March 04, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
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 24
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K926304.
BACT/ALERT SA CULTURE BOTTLE
K020931 · bioMerieux, Inc. · Apr 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · bioMerieux, Inc. · Apr 2002
BACTEC MGIT 960 SYSTEM
K974883 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
BACTEC 9120 SYSTEM
K922475 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
BACTEC 9240 SYSTEM
K915796 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992