Cleared Traditional

K946268 - BACTEC(R) 9000TB SYSTEM

K946268 is an FDA 510(k) clearance for BACTEC 9000TB SYSTEM, manufactured by Becton Dickinson Diagnostic Instrument Systems. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K946268 · Becton Dickinson Diagnostic Instrument Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
515d
Days
Class 1
Risk

K946268 is an FDA 510(k) clearance for the BACTEC(R) 9000TB SYSTEM. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton Dickinson Diagnostic Instrument Systems (Sparks, US). The FDA issued a Cleared decision on May 21, 1996 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Becton Dickinson Diagnostic Instrument Systems devices

FDA 510(k) Submission Details - K946268

510(k) Number K946268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date May 21, 1996
Days to Decision 515 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
413d slower than avg
Panel avg: 102d · This submission: 515d
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 67
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K946268.
BBL MGIT PRODUCTS
K954932 · Becton Dickinson Diagnostic Instrument Systems · Aug 1996
BACTEC 9050 SYSTEM
K962210 · Becton Dickinson Diagnostic Instrument Systems · Aug 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468 · Organon Teknika Corp. · Jul 1996
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
K954921 · Becton Dickinson Diagnostic Instrument Systems · Feb 1996
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
K954925 · Becton Dickinson Diagnostic Instrument Systems · Feb 1996
BACTEC PEDS PLUS/F CULTURE VIALS
K954927 · Becton Dickinson Diagnostic Instrument Systems · Feb 1996