FDA.reportPublic FDA data

510(k) K252637

Device
Community Containers (Flap and Daisy)
Applicant
Keter Canada, Inc.
510(k) number
K252637
Product code
MMK
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-14
Date received
2025-08-20
Regulation
880.5570
Classification name
Container, Sharps
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Lovleen Kaur
Address
205 Market Dr. Milton CA L9T 4Z7 L9T 4Z7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); GuanhongTaizhou Huangyan Guanhong Plastic Steel Products Factory2026-05-22
K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.2025-12-22
K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.2025-10-14
K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.2023-09-14
K222906Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421Ningbo Maxcon Medical Technology Co., Ltd.2023-06-16
K222905Maxcon 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)Ningbo Maxcon Medical Technology Co., Ltd.2023-06-01
K213274Qlicksmart BladeFlask UNIVERSALQlicksmart Pty , Ltd.2022-06-22
K211890Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd.2021-11-17
K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd.2021-09-14
K203305Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc.2021-08-06
K201523Sharps containerZhejiang Gongdong Medical Technology Co., Ltd.2020-11-12
K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc.2019-05-31
K182235OnSite Waste Sharps ContainerBluestone Medical, Inc.2019-05-20
K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd.2019-01-03
K180983Maxcon Two Gallon Chemotherapy ContainerNingbo Maxcon Medical Technology Co., Ltd.2019-01-03