Cleared Traditional

COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K142094) - FDA 510(k) Clearance

Class I Microbiology device.

K142094 · Copan Italia Spa · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
252d
Days
Class 1
Risk

K142094 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 (Marlborough, US). The FDA issued a Cleared decision on April 10, 2015 after a review of 252 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

Submission Details

510(k) Number K142094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date April 10, 2015
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 102d · This submission: 252d
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 37
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K142094.
BioTeke Sterile Disposable Virus Sampling Kit
K211707 · Bioteke Corporation (Wuxi) Co., Ltd. · May 2022
Cultura Collection and Transport System
K201674 · Merit Medical Systems, Inc. · Mar 2021
UriSwab-Urine Collection, Transport and Preservation System
K180052 · Copan Italia Spa · Mar 2018
A.C.T. I
K965149 · Remel Co. · Jan 1997
A.C.T. IV
K965150 · Remel Co. · Jan 1997
A.C.T. III
K965151 · Remel Co. · Jan 1997