Cleared Traditional

K201674 - Cultura Collection and Transport System

K201674 is an FDA 510(k) clearance for Cultura Collection and Transport System, manufactured by Merit Medical Systems, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K201674 · Merit Medical Systems, Inc. · Microbiology device
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Mar 2021
Decision
257d
Days
Class 1
Risk

K201674 is an FDA 510(k) clearance for the Cultura Collection and Transport System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 3, 2021 after a review of 257 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K201674

510(k) Number K201674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2020
Decision Date March 03, 2021
Days to Decision 257 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
155d slower than avg
Panel avg: 102d · This submission: 257d
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 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K201674.
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UriSwab-Urine Collection, Transport and Preservation System
K180052 · Copan Italia Spa · Mar 2018
Greiner Vacuette Urine Count and Culture, Mannitol tube
K163436 · Greiner Bio-One Na, Inc. · Mar 2017
Puritan Fecal Opti-Swab Collection and Transport System
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