Cleared Traditional

UriSwab-Urine Collection, Transport and Preservation System (K180052) - FDA 510(k) Clearance

Class I Microbiology device.

K180052 · Copan Italia Spa · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
74d
Days
Class 1
Risk

K180052 is an FDA 510(k) clearance for the UriSwab-Urine 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 March 23, 2018 after a review of 74 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.

View all Copan Italia Spa devices

Submission Details

510(k) Number K180052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2018
Decision Date March 23, 2018
Days to Decision 74 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
28d faster than avg
Panel avg: 102d · This submission: 74d
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 Consultant

Melissa M. Traylor
Melissa M Traylor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 36
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K180052.
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Cultura Collection and Transport System
K201674 · Merit Medical Systems, Inc. · Mar 2021
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