Cleared Traditional

K160082 - Puritan Opti-Tranz Cary-Blair Collection and Transport System

K160082 is an FDA 510(k) clearance for Puritan Opti-Tranz Cary-Blair Collectio..., manufactured by Puritan Medical Products, LLC. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K160082 · Puritan Medical Products, LLC · Microbiology device
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Jul 2016
Decision
196d
Days
Class 1
Risk

K160082 is an FDA 510(k) clearance for the Puritan Opti-Tranz Cary-Blair 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 July 29, 2016 after a review of 196 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 Puritan Medical Products, LLC devices

FDA 510(k) Submission Details - K160082

510(k) Number K160082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2016
Decision Date July 29, 2016
Days to Decision 196 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
94d slower than avg
Panel avg: 102d · This submission: 196d
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 81
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K160082.
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Puritan Fecal Opti-Swab Collection and Transport System
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Para-Fix C&S Medium
K150887 · Medical Chemical Corporation · May 2015
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K142094 · Copan Italia Spa · Apr 2015
MCC Para-Fix CARY BLAIR MEDIUM
K141506 · Medical Chemical Corporation · Feb 2015