PureWay 1.4 Quart Sharps Collector

FDA 510(k) K231484 · Pureway Compliance, Inc.

Substantially Equivalent

510(k) numberK231484

Submission

Device name
PureWay 1.4 Quart Sharps Collector
Applicant
Pureway Compliance, Inc.
Santa Monica, CA, US
Received
May 23, 2023
Decision date
September 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MMK – Container, Sharps
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5570
Specialty
General Hospital

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K260845Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional Tianjin Huahong Technology Co., Ltd.08/05/2026SE
K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…MMK · Traditional Taizhou Huangyan Guanhong Plastic Steel Products…05/22/2026SE
K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)MMK · Traditional Zhejiang Gongdong Medical Technology Co., Ltd.12/22/2025SE
K252637Community Containers (Flap and Daisy)MMK · Traditional Keter Canada, Inc.10/14/2025SE
K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional Pureway Compliance, Inc.10/14/2025SE
K222906Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421MMK · Traditional Ningbo Maxcon Medical Technology Co., Ltd.06/16/2023SE
K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…MMK · Traditional Ningbo Maxcon Medical Technology Co., Ltd.06/01/2023SE
K213274Qlicksmart BladeFlask UNIVERSALMMK · Abbreviated Qlicksmart Pty , Ltd.06/22/2022SE
K211890Promisemed Sharps containerMMK · Traditional Promisemed Hangzhou Meditech Co., Ltd.11/17/2021SE
K211464Nitta M&T Safety BoxMMK · Traditional Nitta M&T (Thailand) Co., Ltd.09/14/2021SE

More from Nitta M&T (Thailand) Co., Ltd.

510(k)DeviceDecision
K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional 10/14/2025SE
K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…MMK · Traditional 09/04/2015SE

Questions and answers

When was PureWay 1.4 Quart Sharps Collector cleared by the FDA?

PureWay 1.4 Quart Sharps Collector (K231484) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 114 days after the submission was received.

What is the product code of K231484?

The FDA product code is MMK – Container, Sharps, a Class II (moderate risk) device regulated under 21 CFR 880.5570.