Cleared Traditional

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

K251874 · Pureway Compliance, Inc. · General Hospital
Oct 2025
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K251874 is an FDA 510(k) clearance for the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013), a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Pureway Compliance, Inc. (Katy, US). The FDA issued a Cleared decision on October 14, 2025, 118 days after receiving the submission on June 18, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K251874 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2025
Decision Date October 14, 2025
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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