Cleared Traditional

K232357 - Copan Universal Transport Medium (UTM-R...

K232357 is an FDA 510(k) clearance for Copan Universal Transport Medium (UTM-R..., manufactured by Copan Italia Spa. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K232357 · Copan Italia Spa · Microbiology device
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Apr 2024
Decision
262d
Days
Class 1
Risk

K232357 is an FDA 510(k) clearance for the Copan Universal Transport Medium (UTM-RT) System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on April 25, 2024 after a review of 262 days - an extended review 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: 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 Copan Italia Spa devices

FDA 510(k) Submission Details - K232357

510(k) Number K232357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2023
Decision Date April 25, 2024
Days to Decision 262 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
160d slower than avg
Panel avg: 102d · This submission: 262d
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 58
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