Container, Sharps
FDA product code MMK · Class II (moderate risk) · 21 CFR 880.5570 · General Hospital
114510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Bemis Mfg. Co. 7
- Anago, Inc. 5
- Sage Products, Inc. 5
- Ningbo Maxcon Medical Technology Co., Ltd. 4
- Richard-Allan Medical Ind., Inc. 3
- Oak Ridge Products, LLC 3
- Pureway Compliance, Inc. 3
- International Marketing Specialists, Inc. 2
- Jain Surgical Equipment, Inc. 2
- Rehrig Pacific Company 2
- Biosystems 2
- Ultimed, Inc. 2
- Industrial Water Solutions, Inc. 2
- Devon Industries, Inc. 2
- Zhejiang Gongdong Medical Technology Co., Ltd. 2
- Sterilogic Waste Systems, Inc. 2
- Medline Industries, LP 2
- Kleen Test Products 2
- The Daniels Corp. 2
- Sharps Compliance, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/05/2026SE |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…MMK · Traditional | Taizhou Huangyan Guanhong Plastic Steel Products… | 05/22/2026SE |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)MMK · Traditional | Zhejiang Gongdong Medical Technology Co., Ltd. | 12/22/2025SE |
| K252637 | Community Containers (Flap and Daisy)MMK · Traditional | Keter Canada, Inc. | 10/14/2025SE |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional | Pureway Compliance, Inc. | 10/14/2025SE |
| K231484 | PureWay 1.4 Quart Sharps CollectorMMK · Traditional | Pureway Compliance, Inc. | 09/14/2023SE |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/16/2023SE |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/01/2023SE |
| K213274 | Qlicksmart BladeFlask UNIVERSALMMK · Abbreviated | Qlicksmart Pty , Ltd. | 06/22/2022SE |
| K211890 | Promisemed Sharps containerMMK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 11/17/2021SE |
| K211464 | Nitta M&T Safety BoxMMK · Traditional | Nitta M&T (Thailand) Co., Ltd. | 09/14/2021SE |
| K203305 | Tiger Reusable Sharps ContainerMMK · Traditional | International Marketing Specialists, Inc. | 08/06/2021SE |
| K201523 | Sharps containerMMK · Traditional | Zhejiang Gongdong Medical Technology Co., Ltd. | 11/12/2020SE |
| K190240 | Tiger Sharps ContainersMMK · Traditional | International Marketing Specialists, Inc. | 05/31/2019SE |
| K182235 | OnSite Waste Sharps ContainerMMK · Traditional | Bluestone Medical, Inc. | 05/20/2019SE |
| K180984 | Maxcon Sharps ContainerMMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 01/03/2019SE |
| K180983 | Maxcon Two Gallon Chemotherapy ContainerMMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 01/03/2019SE |
| K172719 | HealthBeacon HB2 Sharps BinMMK · Traditional | Healthbeacon, Ltd. | 05/11/2018SE |
| K170513 | MAUSER PG II Sharps ContainerMMK · Traditional | Mauzer USA, LLC | 11/01/2017SE |
| K153274 | Med-Tainer Single Deposit ContainerMMK · Traditional | Snyder Industries, Inc. | 08/04/2016SE |
| K153363 | Red2Green Reusable Sharps ContainerMMK · Traditional | Triumvirate Environmental, Inc. | 07/26/2016SE |
| K161180 | Oak Ridge Products Sharps ContainersMMK · Traditional | Oak Ridge Products, LLC | 06/09/2016SE |
| K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixMMK · Traditional | North American Rescue, LLC | 05/31/2016SE |
| K143693 | Medline Sharps ContainersMMK · Traditional | Medline Industries, Inc. | 11/06/2015SE |
| K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…MMK · Traditional | Pureway Compliance, Inc. | 09/04/2015SE |
| K150333 | MedSource Sharps DartMMK · Traditional | Medsource International, LLC | 05/08/2015SE |
| K140285 | B Travelsavvy Sharps ContainerMMK · Traditional | Bellegrove Medical Supply, Inc. | 12/04/2014SE |
| K141759 | Oak Ridge Products Multi-Purpose Sharps ContainersMMK · Traditional | Oak Ridge Products, LLC | 10/24/2014SE |
| K132476 | Sharps ContainerMMK · Traditional | Grp & Associates | 05/02/2014SE |
| K131708 | BWCSH-1 Sharps ContainerMMK · Traditional | Bradford Wright Companies, Inc. | 03/10/2014SE |
| K132767 | Medline Sharps ContainerMMK · Traditional | Medline Industries, Inc. | 02/03/2014SE |
| K132792 | Ecoship Disposable Sharps Container, Ecoship Disposable Sharps ContainerMMK · Traditional | Daniels Sharpsmart, Inc. | 01/31/2014SE |
| K132007 | Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red…MMK · Traditional | Stericycle, Inc. | 12/27/2013SE |
| K133031 | Sharpsology 2MMK · Traditional | Industrial Water Solutions, Inc. | 11/15/2013SE |
| K123807 | SharpscanMMK · Traditional | Medical Engineering Development Solutions, Inc. | 07/23/2013SE |
| K131087 | Sharpstank Reusable Sharps ContainerMMK · Abbreviated | Rehrig Pacific Company | 07/12/2013SE |
| K130281 | Oak Ridge Products Sharp ContainerMMK · Abbreviated | Oak Ridge Products, LLC | 06/21/2013SE |
| K111085 | Sharps Tank Reusable Sharps ContainerMMK · Abbreviated | Rehrig Pacific Company | 04/25/2012SE |
| K112774 | BD Recykleen Sharps CollectorsMMK · Traditional | Becton, Dickinson and Company | 03/28/2012SE |
| K110262 | Sharps ContainerMMK · Traditional | Noble Marketing | 04/05/2011SE |
| K101567 | Sharps ContainerMMK · Traditional | Cixi Leinuo Plastic Co., Ltd. | 09/02/2010SE |
| K091736 | Sharpsmart Disposable Sharps Container, Model S2MMK · Traditional | Daniels Corporation Pty, Inc. | 10/30/2009SE |
| K091690 | Sharp ChuteMMK · Traditional | Heathrow Scientific, LLC | 07/28/2009SE |
| K090157 | Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS)…MMK · Traditional | Wcm Waste & Compliance Management, Inc. | 05/04/2009SE |
| K083511 | Enviro Sharp Solutions 3MMK · Traditional | Industrial Water Solutions, Inc. | 03/03/2009SE |
| K083129 | Sharps Compliance ContainerMMK · Traditional | Sharps Compliance, Inc. | 12/15/2008SE |
| K082042 | Gongdong Disposable Sharp ContainerMMK · Traditional | Zhejiang Gongdong Medical Plastic Factory | 09/03/2008SE |
| K081821 | D.A.R.T. Pro Kit (D.A.R.T. Pro Handle and X-Tractor Tip)MMK · Traditional | Global Pathogen Solutions, Inc. | 09/02/2008SE |
| K073577 | Sharps Transport Tube, Model 50035MMK · Traditional | Sharps Compliance, Inc. | 06/23/2008SE |
| K081449 | Ultiguard Home Insulin Pen Needle Dispenser and Sharps ContainerMMK · Traditional | Ultimed, Inc. | 06/03/2008SE |
| K071517 | Ap Medical Sharps Containers 0,6-12 Lt.MMK · Abbreviated | A.B.M. Italia S.P.A | 04/02/2008SE |
| K072667 | Sharps Away Disposable ContainerMMK · Traditional | Solutions, Inc. | 10/10/2007SE |
| K070577 | On the Go SharpsMMK · Traditional | Medport, Inc. | 07/13/2007SE |
| K063722 | Sekurit Sharps Collection ContainerMMK · Traditional | Techen Safety, Inc. | 03/05/2007SE |
| K063666 | Sharps Container, Model 039-413MMK · Traditional | Biodex Medical Systems, Inc. | 01/25/2007SE |
| K060037 | FitpackMMK · Traditional | Asp Plastics Pty , Ltd. | 07/25/2006SE |
| K021983 | Ulti Guard Home Insulin Syringe ContainerMMK · Traditional | Ultimed, Inc. | 09/16/2002SE |
| K020664 | Sterisharp 3-GALLON RSDC, Model RSDC3GMMK · Traditional | Sterilogic Waste Systems, Inc. | 05/14/2002SE |
| K001337 | Daniels Sharpsmart Reusable Sharps ContainerMMK · Traditional | The Daniels Corp. | 07/05/2000SE |
| K991612 | Sterisharp 2.5-GALLON RSDC, Model #RSDC2.5GMMK · Traditional | Sterilogic Waste Systems, Inc. | 05/28/1999SE |
| K983367 | QlicksmartMMK · Traditional | Handren Assoc. | 11/06/1998SE |
| K982781 | Demolizer #47 One-Gallon Point of Generation Sharps ContainerMMK · Traditional | Thermal Waste Technology, Inc. | 09/30/1998SE |
| K980490 | Sage Products Inc, Sharps Disposal Containers with Screw Top CapsMMK · Traditional | Sage Products, Inc. | 02/24/1998SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | Graphic Controls Corp. | 03/27/1997SE |
| K964858 | Bemis Two Gallon Chemotherapy ContainerMMK · Traditional | Bemis Mfg. Co. | 02/11/1997SE |
| K955514 | Sharps Safe 1.5 & Sharps Safe 2.0MMK · Traditional | Dura-Vac Products | 08/01/1996SE |
| K960525 | Bemis One Quart Phlebotomy Container (Part Number 100)MMK · Traditional | Bemis Mfg. Co. | 03/28/1996SE |
| K953797 | Sharps Disposal ContainersMMK · Traditional | Bemis Mfg. Co. | 11/27/1995SE |
| K950898 | Biobox with Funnel Top (Small, Medium, Large, and X-Large)MMK · Traditional | Biosystems | 08/24/1995SE |
| K950897 | Biobox Traptop (Small, Medium, Large and X-Large)MMK · Traditional | Biosystems | 08/24/1995SE |
| K950340 | Ight and Eleven Gallon Sharps and Chemotherapy ContainersMMK · Traditional | Bemis Mfg. Co. | 06/02/1995SE |
| K943660 | Phlebotomy Sharps Disposal ContainersMMK · Traditional | Sage Products, Inc. | 03/22/1995SE |
| K943659 | Ancillary and Large Volume Sharps Disposal ContainersMMK · Traditional | Sage Products, Inc. | 03/22/1995SE |
| K943658 | Chemotherapy Waste Disposal ContainersMMK · Traditional | Sage Products, Inc. | 03/22/1995SE |
| K942902 | Sharps-Tainer Small Opening W/Needle RemoverMMK · Traditional | Winfield Co., Inc. | 12/15/1994SE |
| K945197 | The Sharps Collection and Disposal SystemMMK · Traditional | Devon Industries, Inc. | 12/02/1994SE |
| K943138 | Vacutainer Brand Needle Disposal ContainerMMK · Traditional | Med-Safe Systems, Inc. | 11/28/1994SE |
| K941991 | In-Room and SharpstarMMK · Traditional | Sage Products, Inc. | 08/29/1994SE |
| K941665 | Sharps Disposal Container/PhlebotomyMMK · Traditional | Bemis Mfg. Co. | 05/23/1994SE |
| K941664 | Sharp Disposal Containers Wall SafeMMK · Traditional | Bemis Mfg. Co. | 05/23/1994SE |
| K931664 | Sharps Disposable ContainersMMK · Traditional | Bemis Mfg. Co. | 05/23/1994SE |
| K923512 | Operating Room Needle CounterMMK · Traditional | Sharp-Trap, Inc. | 11/23/1992SE |
| K921913 | Hypo-GardMMK · Traditional | Epi Medical Products, Inc. | 07/24/1992SE |
| K915067 | Disposable Needle Counters & Disposable SystemsMMK · Traditional | American Medical Corp. | 03/11/1992SE |
| K913446 | Ican Needle CountersMMK · Traditional | Icn Pharmaceuticals, Inc. | 09/13/1991SE |
| K911077 | Jain Suture Package CounterMMK · Traditional | Jain Surgical Equipment, Inc. | 05/31/1991SE |
| K911076 | Jain Quick CountMMK · Traditional | Jain Surgical Equipment, Inc. | 05/30/1991SE |
| K910516 | Disposal Pad for SharpsMMK · Traditional | Visitec Co. | 04/29/1991SE |
| K904148 | Preven-A-StikMMK · Traditional | Preven-A-Stik, Inc. | 11/21/1990SE |
| K903947 | Qualtex Needle CountersMMK · Traditional | Deroyal Industries, Inc. | 10/30/1990SE |
| K897095 | Disposineedle Sharps Disposal UnitMMK · Traditional | Specialites Septodont | 01/17/1990SE |
| K896195 | Needle Syringe Disposal DeviceMMK · Traditional | Advanced Medical Components, Inc. | 11/27/1989SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | Richard-Allan Medical Ind., Inc. | 02/27/1989SE |
| K884448 | BlademateMMK · Traditional | V.I.R. Engineering, Inc. | 11/17/1988SE |
| K872313 | Needle & Blade Counter & Disposal UnitMMK · Traditional | Gary Plastic Packaging Corp. | 07/02/1987SE |
| K861319 | Disposable Needle Counter (20-560)MMK · Traditional | Anago, Inc. | 05/02/1986SE |
| K861317 | Disposable Needle Counter (20-530)MMK · Traditional | Anago, Inc. | 05/02/1986SE |
| K861316 | Disposable Needle Counter (20-240)MMK · Traditional | Anago, Inc. | 05/02/1986SE |
| K861307 | Disposable Needle CounterMMK · Traditional | Anago, Inc. | 05/02/1986SE |
| K844654 | Sharp Collection System-Sharp-A-GatorMMK · Traditional | Devon Industries, Inc. | 12/12/1984SE |
| K822735 | Sure-Count Disposable Needle CounterMMK · Traditional | Geneva Laboratories, Inc. | 03/09/1983SE |
| K830275 | Needelet Handler for SharpsMMK · Traditional | Ritmed, Inc. | 03/08/1983SE |
| K821394 | Suture-Safe 40 Adhesive Needle CounterMMK · Traditional | Kleen Test Products | 06/03/1982SE |
| K811997 | Sharps SafeMMK · Traditional | Instra-Metics, Inc. | 08/18/1981SE |
| K810134 | Keep-Account Sharps Disposal SystemMMK · Traditional | Info-Chem | 02/26/1981SE |
| K810208 | Blade SafeMMK · Traditional | Instranetics, Inc. | 02/12/1981SE |
| K801259 | Needle Counter-Sure COUNT/100 CountMMK · Traditional | Kleen Test Products | 06/09/1980SE |
| K792016 | Discard-A-Pad 40-COUNT Sharps DisposalMMK · Traditional | Arbrook Mfg. Corp. | 10/26/1979SE |
| K790661 | Protector IIMMK · Traditional | Richard-Allan Medical Ind., Inc. | 04/12/1979SE |
| K790405 | Anchor Brand Count-TainerMMK · Traditional | Anchor Products Co. | 03/26/1979SE |
| K790039 | Counter, Disposable Surgical NeedleMMK · Traditional | Anago, Inc. | 01/17/1979SE |
| K781791 | Board, Disposable Control CountMMK · Traditional | Dexide, Inc. | 11/08/1978SE |
| K771791 | Needle CountingMMK · Traditional | Chase Mfg. Co. | 10/04/1977SE |
| K771611 | ProtectorMMK · Traditional | Richard-Allan Medical Ind., Inc. | 09/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0170-2007 | 5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red…The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble… | Bemis Health Care,Inc | 08/23/2006Terminated |
| Z-0056-2007 | Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per…The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691… | EM Innovations Inc | 04/03/2006Terminated |