Cleared Traditional

BACTEC FUNGAL MEDIUM (K954923) - FDA 510(k) Clearance

Class I Microbiology device.

K954923 · Becton Dickinson Diagnostic Instrument Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
392d
Days
Class 1
Risk

K954923 is an FDA 510(k) clearance for the BACTEC FUNGAL MEDIUM. Classified as Monitor, Microbial Growth (product code JTA), Class I - General Controls.

Submitted by Becton Dickinson Diagnostic Instrument Systems (Sparks, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 392 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: Standard predicate-based submission. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K954923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1995
Decision Date November 21, 1996
Days to Decision 392 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 102d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTA Monitor, Microbial Growth
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 - JTA Monitor, Microbial Growth

All 10
Devices cleared under the same product code (JTA) and FDA review panel - the closest regulatory comparables to K954923.
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K792575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1979