Cleared Traditional

Community Containers (Flap and Daisy)

K252637 · Keter Canada, Inc. · General Hospital
Oct 2025
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K252637 is an FDA 510(k) clearance for the Community Containers (Flap and Daisy), a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Keter Canada, Inc. (Milton, CA). The FDA issued a Cleared decision on October 14, 2025, 55 days after receiving the submission on August 20, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K252637 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2025
Decision Date October 14, 2025
Days to Decision 55 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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