Cleared Traditional

K113249 - TRANSPORT CULTURE MEDIUM DEVICE

K113249 is an FDA 510(k) clearance for TRANSPORT CULTURE MEDIUM DEVICE, 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 119-day FDA review.

K113249 · Puritan Medical Products, LLC · Microbiology device
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Mar 2012
Decision
119d
Days
Class 1
Risk

K113249 is an FDA 510(k) clearance for the TRANSPORT CULTURE MEDIUM DEVICE. 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 March 1, 2012 after a review of 119 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

FDA 510(k) Submission Details - K113249

510(k) Number K113249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2011
Decision Date March 01, 2012
Days to Decision 119 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
17d slower than avg
Panel avg: 102d · This submission: 119d
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 60
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A.C.T. I
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A.C.T. IV
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