Cleared Traditional

K954932 - BBL MGIT PRODUCTS

K954932 is an FDA 510(k) clearance for BBL MGIT PRODUCTS, 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 299-day FDA review.

K954932 · Becton Dickinson Diagnostic Instrument Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
299d
Days
Class 1
Risk

K954932 is an FDA 510(k) clearance for the BBL MGIT PRODUCTS. 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 August 21, 1996 after a review of 299 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 Diagnostic Instrument Systems devices

FDA 510(k) Submission Details - K954932

510(k) Number K954932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date August 21, 1996
Days to Decision 299 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
197d slower than avg
Panel avg: 102d · This submission: 299d
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 K954932.
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp. · Nov 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · Becton Dickinson Microbiology Systems · Aug 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · Accumed Intl., Inc. · Aug 1997
BACTEC 9050 SYSTEM
K962210 · Becton Dickinson Diagnostic Instrument Systems · Aug 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468 · Organon Teknika Corp. · Jul 1996
BACTEC(R) 9000TB SYSTEM
K946268 · Becton Dickinson Diagnostic Instrument Systems · May 1996