MMK · Container, Sharps
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | MMK |
|---|---|
| Device Name | Container, Sharps |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 112)
Showing 20 most recent of 112 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | Dec 22, 2025 | SESE |
| K252637 | Community Containers (Flap and Daisy) | Keter Canada, Inc. | Oct 14, 2025 | SESE |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | Oct 14, 2025 | SESE |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | Sep 14, 2023 | SESE |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd. | Jun 16, 2023 | SESE |
| K222905 | 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) | Ningbo Maxcon Medical Technology Co., Ltd. | Jun 1, 2023 | SESE |
| K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty , Ltd. | Jun 22, 2022 | SESE |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | Nov 17, 2021 | SESE |
| K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | Sep 14, 2021 | SESE |
| K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | Aug 6, 2021 | SESE |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | Nov 12, 2020 | SESE |
| K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | May 31, 2019 | SESE |
| K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | May 20, 2019 | SESE |
| K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | Jan 3, 2019 | SESE |
| K180983 | Maxcon Two Gallon Chemotherapy Container | Ningbo Maxcon Medical Technology Co., Ltd. | Jan 3, 2019 | SESE |
| K172719 | HealthBeacon HB2 Sharps Bin | Healthbeacon, Ltd. | May 11, 2018 | SESE |
| K170513 | MAUSER PG II Sharps Container | Mauzer USA, LLC | Nov 1, 2017 | SESE |
| K153274 | Med-Tainer Single Deposit Container | Snyder Industries, Inc. | Aug 4, 2016 | SESE |
| K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | Jul 26, 2016 | SESE |
| K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | Jun 9, 2016 | SESE |
Top Applicants
- Bemis Mfg. Co. — 7 clearances
- Anago, Inc. — 5 clearances
- Sage Products, Inc. — 5 clearances
- Ningbo Maxcon Medical Technology Co., Ltd. — 4 clearances
- Oak Ridge Products, LLC — 3 clearances
