510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1427 of 3531

510(k) clearances, page 1427 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030787	Shiley Flextra Tracheostomy Tube	Medtronic, Inc.	JOH	Class II	2003-11-14
K022304	Accumap Automatic Perimeter	Objectivision Pty, Ltd.	GWE	Class II	2003-11-14
K033446	Apex93, Apex87, Apex84, Apex85, Apex77, E-Sarang 88 and E-Sarang 82	We Dong Myung Dental Industrial Co., Ltd.	EJT	Class II	2003-11-13
K033373	Monoject Insulin Syringe	Tyco Healthcare	FMI	Class II	2003-11-13
K033252	Modification to Stryker Bioabsorbable Interference Screw System	Stryker Corp.	HWC	Class II	2003-11-13
K033144	Defibtech Electrode Adapter, Model Dac-300 Series	Defibtech LLC	MKJ	Class III	2003-11-13
K032964	Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments	Exactech, Inc.	LPH	Class II	2003-11-13
K032934	Mps Acacia Safeguard Huber Device	Mps Acacia	FPA	Class II	2003-11-13
K032921	Premise	Sybron Dental Specialties, Inc.	EBF	Class II	2003-11-13
K032879	Navigator I	Adaptive Healthcare Technologies, Inc.	INI	Class II	2003-11-13
K032824	Stelkast Unicondylar Knee System	Globus Medical, Inc.	HSX	Class II	2003-11-13
K032809	Hospital Spacer	Respironics Healthscan, Inc.	CAF	Class II	2003-11-13
K032783	Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves	Zibo Blue Sail Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2003-11-13
K032781	Blue Sail (Brand) Powder-Free Vinyl Patient Examination Gloves	Zibo Blue Sail Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2003-11-13
K032744	Alveolus Inc., Tb-Sts Tracheobronchial Stent System	Alveolus, Inc.	JCT	Class II	2003-11-13
K032691	Zoll Autoclavable Internal Handles	ZOLL Medical Corporation	LDD	Class II	2003-11-13
K032476	Nuvasive Mesh	NuVasive Inc	MQP	Class II	2003-11-13
K032460	Profile Bbl System	Sciton, Inc.	GEX	Class II	2003-11-13
K032444	Nitrile Powder-Free Examination Gloves with Lotion Coating and Use for Chemotherapy	Cardinalhealth	LZC	Class I	2003-11-13
K031793	Dentatus Osciomat	Dentatus USA Ltd.	DZH	Class II	2003-11-13
K031546	Rainbow Gt-4A Pain Relief Machine	Sino-Us Information, Inc.	GZJ	Class II	2003-11-13
K031170	Powder Free Synthetic Vinyl Patient Examination Gloves, White Brothers	Long First (Xiamen) Co., Ltd.	LYZ	Class I	2003-11-13
K021594	Copc Band	Center for Orthotic and Prosthetic Care,Llc	MVA	Class II	2003-11-13
K033435	E-Sarang 86, Dm78, Dm55	We Dong Myung Dental Industrial Co., Ltd.	EJT	Class II	2003-11-12
K033434	Bestaloy	We Dong Myung Dental Industrial Co., Ltd.	EJJ	Class II	2003-11-12
K033347	Modification to: Hi-Art System	Accuray Incorporated	IYE	Class II	2003-11-12
K033304	Modification to Dash 3000/4000 Patient Monitor	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-11-12
K033239	Be-Mobile 4-Wheeled Electric Scooter, Model Dk S500	Tung Keng Enterprise Co., Ltd.	INI	Class II	2003-11-12
K033219	Be-Mobile 4-Wheeled Electric Scooter, Model Dk S600	Tung Keng Enterprise Co., Ltd.	INI	Class II	2003-11-12
K033204	Esg 4-Wheel Scooter, Esg-03	EMG Technology Co., Ltd.	INI	Class II	2003-11-12
K033199	Compact Digital Cardiac Camera (Cdcc)	Is2 Medical Systems, Inc.	KPS	Class II	2003-11-12
K033097	Taiwan King Strong Powered Wheelchair, Tp 02	Taiwan King Strong Co., Ltd.	ITI	Class II	2003-11-12
K033066	Xiscan 4000 Transportable Imaging System	Xitec Holdings, LLC	OXO	Class II	2003-11-12
K033021	Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads	Kimberly-Clark Corporation	DWJ	Class II	2003-11-12
K032861	Vitek 2 Gram Negative Moxifloxacin	bioMerieux, Inc.	LON	Class II	2003-11-12
K032852	Modification to: Autopulse Resuscitation System Model 100	Revivant Corp.	DRM	Class II	2003-11-12
K032669	Y.e.s. Powered Wheelchair, Model T200	Yeou Eir Shuen Machinery Co., Ltd.	ITN	Class I	2003-11-12
K032646	Elecsys Probnp Immunoassay	Roche Diagnostics GmbH	NBC	Class II	2003-11-12
K032627	Ultradent Citric Acid 10% Solution	Ultradent Products Inc.	KJJ	Unclassified	2003-11-12
K032617	Wu's 4-Wheeled Scooter, Wt-L4jr	Wu's Tech Co., Ltd.	INI	Class II	2003-11-12
K032520	Ortrautek Trauma System	Tekka	JEY	Class II	2003-11-12
K032519	Endo Pat 2000	Itamar Medical	DQK	Class II	2003-11-12
K032512	Y.e.s Powered Wheelchair. T180	Yeou Eir Shuen Machinery Co., Ltd.	ITI	Class II	2003-11-12
K031820	Electronic Muscle Massage, Models Be-550 and Be-660	Multinational	IPF	Class II	2003-11-12
K031799	Miele Dental Thermal Disinfector, Model G7881	Miele Inc.	LDS	Class II	2003-11-12
K031798	Good Morning Test	Standard Diagnostics, Inc.	LCX	Class II	2003-11-12
K031559	Renu Medical Reporcessed Compressible Limb Sleeves	Renu Medical, Inc.	JOW	Class II	2003-11-12
K031494	Doc's Best White Copper Cement	Cooley & Cooley, Ltd.	EMA	Class II	2003-11-12
K023120	Oxycon Mobile	Erich Jaeger, Inc.	BZC	Class II	2003-11-12
K033427	Modification to En-Bloc Biopsy System	Neothermia Corp.	KNW	Class II	2003-11-10