Cleared Traditional

Puritan PurSafe Plus Collection and Transport System

K242820 · Puritan Medical Products, LLC · Microbiology

May 2025

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K242820 is an FDA 510(k) clearance for the Puritan PurSafe Plus Collection and Transport System, a Microbial Nucleic Acid Storage And Stabilization Device (Class II — Special Controls, product code QBD), submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on May 27, 2025, 251 days after receiving the submission on September 18, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2950.

Submission Details

510(k) Number	K242820 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2024
Decision Date	May 27, 2025
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QBD — Microbial Nucleic Acid Storage And Stabilization Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.2950
Definition	Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.