Community Containers (Flap and Daisy)

FDA 510(k) K252637 · Keter Canada, Inc.

Substantially Equivalent

510(k) numberK252637

Submission

Device name
Community Containers (Flap and Daisy)
Applicant
Keter Canada, Inc.
Milton, CA
Received
August 20, 2025
Decision date
October 14, 2025
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

Other 510(k)s with product code MMK

510(k)DeviceApplicantDecision
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
K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional Pureway Compliance, Inc.10/14/2025SE
K231484PureWay 1.4 Quart Sharps CollectorMMK · Traditional Pureway Compliance, Inc.09/14/2023SE
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

Questions and answers

When was Community Containers (Flap and Daisy) cleared by the FDA?

Community Containers (Flap and Daisy) (K252637) received a 510(k) decision of Substantially Equivalent on October 14, 2025, 55 days after the submission was received.

What is the product code of K252637?

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