Cleared Traditional

K142366 - Puritan OptiTranz Liquid Stuart Collection and Transport System (FDA 510(k) Clearance)

Class I Microbiology device.

K142366 · Puritan Medical Products, LLC · Microbiology device
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Jan 2015
Decision
137d
Days
Class 1
Risk

K142366 is an FDA 510(k) clearance for the Puritan OptiTranz Liquid Stuart Collection and Transport System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 137 days - within the typical 510(k) review window.

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 Puritan Medical Products, LLC devices

Submission Details

510(k) Number K142366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date January 09, 2015
Days to Decision 137 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
35d slower than avg
Panel avg: 102d · This submission: 137d
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
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