Cleared Traditional

K951539 - ENTEROCOCCUS SCREENING MEDIUM

K951539 is the FDA 510(k) clearance for ENTEROCOCCUS SCREENING MEDIUM by Becton Dickinson Microbiology Systems. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K951539 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
71d
Days
Class 2
Risk

K951539 is an FDA 510(k) clearance for the ENTEROCOCCUS SCREENING MEDIUM. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K951539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date June 13, 1995
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 364
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K951539.
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · Baxter Diagnostics, Inc. · Jul 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · Radiometer America, Inc. · Jul 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · Ab Biodisk · Jul 1995
E TEST FOR OFLOXACIN
K946364 · Ab Biodisk · May 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · Baxter Diagnostics, Inc. · Apr 1995
SCEPTOR SYSTEM PANELS
K950123 · Becton Dickinson Microbiology Systems · Mar 1995