MMK · Class II · 21 CFR 880.5570

FDA Product Code MMK: Container, Sharps

Leading manufacturers include Ningbo Maxcon Medical Technology Co., Ltd., International Marketing Specialists, Inc. and Zhejiang Gongdong Medical Technology Co., Ltd..

113
Total
113
Cleared
122d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 109d avg (recent)

FDA 510(k) Cleared Container, Sharps Devices (Product Code MMK)

113 devices
1–24 of 113
Cleared May 22, 2026
Guanhong Sharps Container (GHW-1F1)
K253773
Taizhou Huangyan Guanhong Plastic Steel Products Factory
General Hospital · 177d
Cleared Dec 22, 2025
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222
Zhejiang Gongdong Medical Technology Co., Ltd.
General Hospital · 84d
Cleared Oct 14, 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874
Pureway Compliance, Inc.
General Hospital · 118d
Cleared Oct 14, 2025
Community Containers (Flap and Daisy)
K252637
Keter Canada, Inc.
General Hospital · 55d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484
Pureway Compliance, Inc.
General Hospital · 114d
Cleared Jun 16, 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906
Ningbo Maxcon Medical Technology Co., Ltd.
General Hospital · 266d
Cleared Jun 01, 2023
Maxcon 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)
K222905
Ningbo Maxcon Medical Technology Co., Ltd.
General Hospital · 251d
Cleared Jun 22, 2022
Qlicksmart BladeFlask UNIVERSAL
K213274
Qlicksmart Pty , Ltd.
General Hospital · 265d
Cleared Nov 17, 2021
Promisemed Sharps container
K211890
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 149d
Cleared Sep 14, 2021
Nitta M&T Safety Box
K211464
Nitta M&T (Thailand) Co., Ltd.
General Hospital · 126d
Cleared Aug 06, 2021
Tiger Reusable Sharps Container
K203305
International Marketing Specialists, Inc.
General Hospital · 270d
Cleared Nov 12, 2020
Sharps container
K201523
Zhejiang Gongdong Medical Technology Co., Ltd.
General Hospital · 157d
Cleared May 31, 2019
Tiger Sharps Containers
K190240
International Marketing Specialists, Inc.
General Hospital · 114d
Cleared May 20, 2019
OnSite Waste Sharps Container
K182235
Bluestone Medical, Inc.
General Hospital · 276d
Cleared Jan 03, 2019
Maxcon Two Gallon Chemotherapy Container
K180983
Ningbo Maxcon Medical Technology Co., Ltd.
General Hospital · 265d
Cleared Jan 03, 2019
Maxcon Sharps Container
K180984
Ningbo Maxcon Medical Technology Co., Ltd.
General Hospital · 265d
Cleared May 11, 2018
HealthBeacon HB2 Sharps Bin
K172719
Healthbeacon, Ltd.
General Hospital · 245d
Cleared Nov 06, 2015
MEDLINE SHARPS CONTAINERS
K143693
Medline Industries, Inc.
General Hospital · 317d
Cleared Feb 03, 2014
MEDLINE SHARPS CONTAINER
K132767
Medline Industries, Inc.
General Hospital · 152d

About Product Code MMK - Regulatory Context

510(k) Submission Activity

113 total 510(k) submissions under product code MMK since 1977, with 113 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MMK Product Code

FDA review times for MMK submissions have been consistent, averaging 109 days recently vs 122 days historically.

MMK devices are reviewed by the General Hospital panel. Browse all General Hospital devices →