Cleared Traditional

PureWay 1.4 Quart Sharps Collector

K231484 · Pureway Compliance, Inc. · General Hospital
Sep 2023
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K231484 is an FDA 510(k) clearance for the PureWay 1.4 Quart Sharps Collector, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Pureway Compliance, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 14, 2023, 114 days after receiving the submission on May 23, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K231484 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2023
Decision Date September 14, 2023
Days to Decision 114 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

Similar Devices — MMK Container, Sharps

All 111
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · Pureway Compliance, Inc. · Oct 2025
Community Containers (Flap and Daisy)
K252637 · Keter Canada, Inc. · Oct 2025
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
K222905 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023
Qlicksmart BladeFlask UNIVERSAL
K213274 · Qlicksmart Pty , Ltd. · Jun 2022