Cleared Traditional

K220052 - Copan FecalSwab Collection, Transport and Preservation System (FDA 510(k) Clearance)

Class I Microbiology device.

K220052 · Copan Italia Spa · Microbiology device
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Dec 2022
Decision
344d
Days
Class 1
Risk

K220052 is an FDA 510(k) clearance for the Copan FecalSwab Collection, Transport and Preservation 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 December 16, 2022 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Copan Italia Spa devices

Submission Details

510(k) Number K220052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2022
Decision Date December 16, 2022
Days to Decision 344 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
242d slower than avg
Panel avg: 102d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 110
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K220052.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
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UriSponge™
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Ensol EnTM Specimen Collection and Transport System
K220908 · Ensol Biosciences, Inc. · Aug 2024
OmniTrans Transport System
K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024