Cleared Traditional

K954923 - BACTEC FUNGAL MEDIUM

K954923 is an FDA 510(k) clearance for BACTEC FUNGAL MEDIUM, manufactured by Becton Dickinson Diagnostic Instrument Systems. The device is a Class 1 Microbiology device with product code JTA cleared through the Traditional 510(k) pathway after a 392-day FDA review.

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

FDA 510(k) Submission Details - K954923

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 102d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

JTA Device Classification - Class 1, General Controls

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 9
Devices cleared under the same product code (JTA) and FDA review panel - the closest regulatory comparables to K954923.
BACTEC NR-860
K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
K853011 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1985
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · American Micro Scan · Sep 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984
BAC-T-SCREEN
K833917 · Marion Laboratories, Inc. · Jan 1984