Product Code: MMK FDA class 2 21 CFR 880.5570

Container, Sharps

General Hospital

The Sharps Container is a rigid, puncture-resistant disposal container designed for the safe collection and disposal of used needles, syringes, lancets, and other sharp medical instruments to prevent needlestick injuries and reduce the risk of bloodborne pathogen transmission among healthcare workers and the public. Classified as a Class 2 device under 21 CFR 880.5570 within the General Hospital specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

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510(k)s

113

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MMK
Device Class: FDA class 2
Regulation Number: 880.5570
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 113 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253773	Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong	May 22, 2026	Substantially Equivalent	Taizhou Huangyan Guanhong Plastic Steel Products Factory
K253222	Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)	Dec 22, 2025	Substantially Equivalent	Zhejiang Gongdong Medical Technology Co., Ltd.
K252637	Community Containers (Flap and Daisy)	Oct 14, 2025	Substantially Equivalent	Keter Canada, Inc.
K251874	PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)	Oct 14, 2025	Substantially Equivalent	Pureway Compliance, Inc.
K231484	PureWay 1.4 Quart Sharps Collector	Sep 14, 2023	Substantially Equivalent	Pureway Compliance, Inc.
K222906	Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421	Jun 16, 2023	Substantially Equivalent	Ningbo Maxcon Medical Technology Co., Ltd.
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)	Jun 01, 2023	Substantially Equivalent	Ningbo Maxcon Medical Technology Co., Ltd.
K213274	Qlicksmart BladeFlask UNIVERSAL	Jun 22, 2022	Substantially Equivalent	Qlicksmart Pty , Ltd.
K211890	Promisemed Sharps container	Nov 17, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K211464	Nitta M&T Safety Box	Sep 14, 2021	Substantially Equivalent	Nitta M&T (Thailand) Co., Ltd.
K203305	Tiger Reusable Sharps Container	Aug 06, 2021	Substantially Equivalent	International Marketing Specialists, Inc.
K201523	Sharps container	Nov 12, 2020	Substantially Equivalent	Zhejiang Gongdong Medical Technology Co., Ltd.
K190240	Tiger Sharps Containers	May 31, 2019	Substantially Equivalent	International Marketing Specialists, Inc.
K182235	OnSite Waste Sharps Container	May 20, 2019	Substantially Equivalent	Bluestone Medical, Inc.
K180984	Maxcon Sharps Container	Jan 03, 2019	Substantially Equivalent	Ningbo Maxcon Medical Technology Co., Ltd.
K180983	Maxcon Two Gallon Chemotherapy Container	Jan 03, 2019	Substantially Equivalent	Ningbo Maxcon Medical Technology Co., Ltd.
K172719	HealthBeacon HB2 Sharps Bin	May 11, 2018	Substantially Equivalent	Healthbeacon, Ltd.
K170513	MAUSER PG II Sharps Container	Nov 01, 2017	Substantially Equivalent	Mauzer USA, LLC
K153274	Med-Tainer Single Deposit Container	Aug 04, 2016	Substantially Equivalent	Snyder Industries, Inc.
K153363	Red2Green Reusable Sharps Container	Jul 26, 2016	Substantially Equivalent	Triumvirate Environmental, Inc.
K161180	Oak Ridge Products Sharps Containers	Jun 09, 2016	Substantially Equivalent	Oak Ridge Products, LLC
K152340	NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six	May 31, 2016	Substantially Equivalent	North American Rescue, LLC
K143693	MEDLINE SHARPS CONTAINERS	Nov 06, 2015	Substantially Equivalent	Medline Industries, Inc.
K151249	PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON	Sep 04, 2015	Substantially Equivalent	Pureway Compliance, Inc.
K150333	MedSource Sharps Dart	May 08, 2015	Substantially Equivalent	Medsource International, LLC
K140285	B TRAVELSAVVY SHARPS CONTAINER	Dec 04, 2014	Substantially Equivalent	Bellegrove Medical Supply, Inc.
K141759	OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS	Oct 24, 2014	Substantially Equivalent	Oak Ridge Products, LLC
K132476	SHARPS CONTAINER	May 02, 2014	Substantially Equivalent	Grp & Associates
K131708	BWCSH-1 SHARPS CONTAINER	Mar 10, 2014	Substantially Equivalent	Bradford Wright Companies, Inc.
K132767	MEDLINE SHARPS CONTAINER	Feb 03, 2014	Substantially Equivalent	Medline Industries, Inc.
K132792	ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER	Jan 31, 2014	Substantially Equivalent	Daniels Sharpsmart, Inc.
K132007	STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU	Dec 27, 2013	Substantially Equivalent	Stericycle, Inc.
K133031	SHARPSOLOGY 2	Nov 15, 2013	Substantially Equivalent	Industrial Water Solutions, Inc.
K123807	SHARPSCAN	Jul 23, 2013	Substantially Equivalent	Medical Engineering Development Solutions, Inc.
K131087	SHARPSTANK REUSABLE SHARPS CONTAINER	Jul 12, 2013	Substantially Equivalent	Rehrig Pacific Company
K130281	OAK RIDGE PRODUCTS SHARP CONTAINER	Jun 21, 2013	Substantially Equivalent	Oak Ridge Products, LLC
K111085	SHARPS TANK REUSABLE SHARPS CONTAINER	Apr 25, 2012	Substantially Equivalent	Rehrig Pacific Company
K112774	BD RECYKLEEN SHARPS COLLECTORS	Mar 28, 2012	Substantially Equivalent	Becton, Dickinson and Company
K110262	SHARPS CONTAINER	Apr 05, 2011	Substantially Equivalent	Noble Marketing
K101567	SHARPS CONTAINER	Sep 02, 2010	Substantially Equivalent	Cixi Leinuo Plastic Co., Ltd.
K091736	SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2	Oct 30, 2009	Substantially Equivalent	Daniels Corporation Pty, Inc.
K091690	SHARP CHUTE	Jul 28, 2009	Substantially Equivalent	Heathrow Scientific, LLC
K090157	ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.	May 04, 2009	Substantially Equivalent	Wcm Waste & Compliance Management, Inc.
K083511	ENVIRO SHARP SOLUTIONS 3	Mar 03, 2009	Substantially Equivalent	Industrial Water Solutions, Inc.
K083129	SHARPS COMPLIANCE CONTAINER	Dec 15, 2008	Substantially Equivalent	Sharps Compliance, Inc.
K082042	GONGDONG DISPOSABLE SHARP CONTAINER	Sep 03, 2008	Substantially Equivalent	Zhejiang Gongdong Medical Plastic Factory
K081821	D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)	Sep 02, 2008	Substantially Equivalent	Global Pathogen Solutions, Inc.
K073577	SHARPS TRANSPORT TUBE, MODEL 50035	Jun 23, 2008	Substantially Equivalent	Sharps Compliance, Inc.
K081449	ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER	Jun 03, 2008	Substantially Equivalent	Ultimed, Inc.
K071517	AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.	Apr 02, 2008	Substantially Equivalent	A.B.M. Italia S.P.A
K072667	SHARPS AWAY DISPOSABLE CONTAINER	Oct 10, 2007	Substantially Equivalent	Solutions, Inc.
K070577	ON THE GO SHARPS	Jul 13, 2007	Substantially Equivalent	Medport, Inc.
K063722	SEKURIT SHARPS COLLECTION CONTAINER	Mar 05, 2007	Substantially Equivalent	Techen Safety, Inc.
K063666	SHARPS CONTAINER, MODEL 039-413	Jan 25, 2007	Substantially Equivalent	Biodex Medical Systems, Inc.
K060037	FITPACK	Jul 25, 2006	Substantially Equivalent	Asp Plastics Pty , Ltd.
K021983	ULTI GUARD HOME INSULIN SYRINGE CONTAINER	Sep 16, 2002	Substantially Equivalent	Ultimed, Inc.
K020664	STERISHARP 3-GALLON RSDC, MODEL RSDC3G	May 14, 2002	Substantially Equivalent	Sterilogic Waste Systems, Inc.
K001337	DANIELS SHARPSMART REUSABLE SHARPS CONTAINER	Jul 05, 2000	Substantially Equivalent	The Daniels Corp.
K991612	STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G	May 28, 1999	Substantially Equivalent	Sterilogic Waste Systems, Inc.
K983367	QLICKSMART	Nov 06, 1998	Substantially Equivalent	Handren Assoc.
K982781	DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER	Sep 30, 1998	Substantially Equivalent	Thermal Waste Technology, Inc.
K980490	SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS	Feb 24, 1998	Substantially Equivalent	Sage Products, Inc.
K964387	POINT OF USE II SHARPS-A-GATOR	Mar 27, 1997	Substantially Equivalent	Graphic Controls Corp.
K964858	BEMIS TWO GALLON CHEMOTHERAPY CONTAINER	Feb 11, 1997	Substantially Equivalent	Bemis Mfg. Co.
K955514	SHARPS SAFE 1.5 & SHARPS SAFE 2.0	Aug 01, 1996	Substantially Equivalent	Dura-Vac Products
K960525	BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)	Mar 28, 1996	Substantially Equivalent	Bemis Mfg. Co.
K953797	SHARPS DISPOSAL CONTAINERS	Nov 27, 1995	Substantially Equivalent	Bemis Mfg. Co.
K950898	BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)	Aug 24, 1995	Substantially Equivalent	Biosystems
K950897	BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)	Aug 24, 1995	Substantially Equivalent	Biosystems
K950340	IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS	Jun 02, 1995	Substantially Equivalent	Bemis Mfg. Co.
K943660	PHLEBOTOMY SHARPS DISPOSAL CONTAINERS	Mar 22, 1995	Substantially Equivalent	Sage Products, Inc.
K943659	ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS	Mar 22, 1995	Substantially Equivalent	Sage Products, Inc.
K943658	CHEMOTHERAPY WASTE DISPOSAL CONTAINERS	Mar 22, 1995	Substantially Equivalent	Sage Products, Inc.
K942902	SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER	Dec 15, 1994	Substantially Equivalent	Winfield Co., Inc.
K945197	THE SHARPS COLLECTION AND DISPOSAL SYSTEM	Dec 02, 1994	Substantially Equivalent	Devon Industries, Inc.
K943138	VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER	Nov 28, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K941991	IN-ROOM AND SHARPSTAR	Aug 29, 1994	Substantially Equivalent	Sage Products, Inc.
K941665	SHARPS DISPOSAL CONTAINER/PHLEBOTOMY	May 23, 1994	Substantially Equivalent	Bemis Mfg. Co.
K941664	SHARP DISPOSAL CONTAINERS WALL SAFE	May 23, 1994	Substantially Equivalent	Bemis Mfg. Co.
K931664	SHARPS DISPOSABLE CONTAINERS	May 23, 1994	Substantially Equivalent	Bemis Mfg. Co.
K923512	OPERATING ROOM NEEDLE COUNTER	Nov 23, 1992	Substantially Equivalent	Sharp-Trap, Inc.
K921913	HYPO-GARD	Jul 24, 1992	Substantially Equivalent	Epi Medical Products, Inc.
K915067	DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS	Mar 11, 1992	Substantially Equivalent	American Medical Corp.
K913446	ICAN NEEDLE COUNTERS	Sep 13, 1991	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K911077	JAIN SUTURE PACKAGE COUNTER	May 31, 1991	Substantially Equivalent	Jain Surgical Equipment, Inc.
K911076	JAIN QUICK COUNT	May 30, 1991	Substantially Equivalent	Jain Surgical Equipment, Inc.
K910516	DISPOSAL PAD FOR SHARPS	Apr 29, 1991	Substantially Equivalent	Visitec Co.
K904148	PREVEN-A-STIK	Nov 21, 1990	Substantially Equivalent	Preven-A-Stik, Inc.
K903947	QUALTEX NEEDLE COUNTERS	Oct 30, 1990	Substantially Equivalent	Deroyal Industries, Inc.
K897095	DISPOSINEEDLE SHARPS DISPOSAL UNIT	Jan 17, 1990	Substantially Equivalent	Specialites Septodont
K896195	NEEDLE SYRINGE DISPOSAL DEVICE	Nov 27, 1989	Substantially Equivalent	Advanced Medical Components, Inc.
K890314	PROTECTOR (SURGICAL INSTRUMENT)	Feb 27, 1989	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K884448	BLADEMATE	Nov 17, 1988	Substantially Equivalent	V.I.R. Engineering, Inc.
K872313	NEEDLE & BLADE COUNTER & DISPOSAL UNIT	Jul 02, 1987	Substantially Equivalent	Gary Plastic Packaging Corp.
K861319	DISPOSABLE NEEDLE COUNTER (20-560)	May 02, 1986	Substantially Equivalent	Anago, Inc.
K861317	DISPOSABLE NEEDLE COUNTER (20-530)	May 02, 1986	Substantially Equivalent	Anago, Inc.
K861316	DISPOSABLE NEEDLE COUNTER (20-240)	May 02, 1986	Substantially Equivalent	Anago, Inc.
K861307	DISPOSABLE NEEDLE COUNTER	May 02, 1986	Substantially Equivalent	Anago, Inc.
K844654	SHARP COLLECTION SYSTEM-SHARP-A-GATOR	Dec 12, 1984	Substantially Equivalent	Devon Industries, Inc.
K822735	SURE-COUNT DISPOSABLE NEEDLE COUNTER	Mar 09, 1983	Substantially Equivalent	Geneva Laboratories, Inc.
K830275	NEEDELET HANDLER FOR SHARPS	Mar 08, 1983	Substantially Equivalent	Ritmed, Inc.
K821394	SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER	Jun 03, 1982	Substantially Equivalent	Kleen Test Products
K811997	SHARPS SAFE	Aug 18, 1981	Substantially Equivalent	Instra-Metics, Inc.
K810134	KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM	Feb 26, 1981	Substantially Equivalent	Info-Chem
K810208	BLADE SAFE	Feb 12, 1981	Substantially Equivalent	Instranetics, Inc.
K801259	NEEDLE COUNTER-SURE COUNT/100 COUNT	Jun 09, 1980	Substantially Equivalent	Kleen Test Products
K792016	DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL	Oct 26, 1979	Substantially Equivalent	Arbrook Mfg. Corp.
K790661	PROTECTOR II	Apr 12, 1979	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K790405	ANCHOR BRAND COUNT-TAINER	Mar 26, 1979	Substantially Equivalent	Anchor Products Co.
K790039	COUNTER, DISPOSABLE SURGICAL NEEDLE	Jan 17, 1979	Substantially Equivalent	Anago, Inc.
K781791	BOARD, DISPOSABLE CONTROL COUNT	Nov 08, 1978	Substantially Equivalent	Dexide, Inc.
K771791	NEEDLE COUNTING	Oct 04, 1977	Substantially Equivalent	Chase Mfg. Co.
K771611	PROTECTOR	Sep 06, 1977	Substantially Equivalent	Richard-Allan Medical Ind., Inc.