FDA Product Code MMK: Container, Sharps
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd., Pureway Compliance, Inc. and Keter Canada, Inc..
FDA 510(k) Cleared Container, Sharps Devices (Product Code MMK)
About Product Code MMK - Regulatory Context
510(k) Submission Activity
112 total 510(k) submissions under product code MMK since 1977, with 112 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under MMK have taken an average of 86 days to reach a decision - down from 122 days historically, suggesting improved FDA processing for this classification.
MMK devices are reviewed by the General Hospital panel. Browse all General Hospital devices →