Cleared Traditional

K946286 - COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM

K946286 is an FDA 510(k) clearance for COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM, manufactured by Copan Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K946286 · Copan Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
73d
Days
Class 1
Risk

K946286 is an FDA 510(k) clearance for the COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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.

FDA 510(k) Submission Details - K946286

510(k) Number K946286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1994
Decision Date March 10, 1995
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 107
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K946286.
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
K946283 · Copan Diagnostics, Inc. · Mar 1995
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K946284 · Copan Diagnostics, Inc. · Mar 1995
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
K946285 · Copan Diagnostics, Inc. · Mar 1995
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K946287 · Copan Diagnostics, Inc. · Mar 1995
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM
K946288 · Copan Diagnostics, Inc. · Mar 1995
KULTSURE STARSWAB (M210), MODIFICATION
K943498 · Ncs Diagnostics, Inc. · Nov 1994
K946286 · COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
Download PDF FDA Summary Copan Diagnostics, In…