Cleared Traditional

K921133 - BACTEC PLUS AEROBIC/F AND ANAEROBIC/F M...

K921133 is the FDA 510(k) clearance for BACTEC PLUS AEROBIC/F AND ANAEROBIC/F M... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code MDB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K921133 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
43d
Days
Class 1
Risk

K921133 is an FDA 510(k) clearance for the BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA. 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 April 22, 1992 after a review of 43 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 K921133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date April 22, 1992
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
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 56
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K921133.
BACTEC 9120 SYSTEM
K922475 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
BACT/ALERT PEDI-BACT
K920249 · Organon Teknika Corp. · Apr 1992
BACTEC 9240 SYSTEM
K915796 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BACT/ALERT (TM)
K903505 · Organon Teknika Corp. · Mar 1991
PENASE
K833888 · Oxoid U.S.A., Inc. · Jan 1984