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 1483 of 3531

510(k) clearances, page 1483 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023686	Aurora Mr-Guided Interventional System	Aurora Imaging Technology, Inc.	LNH	Class II	2003-01-29
K023677	Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)	Opti Medical Systems Inc	LIB	Class I	2003-01-29
K023659	1-Ccd Endocam 5520 System	Richard Wolf Medical Instruments Corp.	FET	Class II	2003-01-29
K022845	Sas Rsv Test	SA Scientific, Ltd	GQG	Class I	2003-01-29
K022807	Meladine Natural Melanin Enhancer, Product Number Ct81602aa	Creative Technologies, Inc.	GEX	Class II	2003-01-29
K022008	Cardima Ablation System	Cardima, Inc.	OCL	Class II	2003-01-29
K030150	Linical Protein 5 Calibration Verifiers Levels a-E for Beckman Coulter Array and Immage Protein Systems	Cliniqa Corporation	JJY	Class I	2003-01-28
K030083	Vaxcel with Pasv Port	Boston Scientific Corporation	LJT	Class II	2003-01-28
K030031	Soft Tissue Anchoring Washers	Accu-Speed, Incorporated	KGS	Class I	2003-01-28
K024373	Modification to Animec, Models Am-2S-4, Am-2S-5, Lt-1-4 & Lt-1-5	Elltec Co., Ltd.	LGZ	Class II	2003-01-28
K024348	Monarch Spine System	Depuyacromed	MNH	Class II	2003-01-28
K024174	Non-Dehp, Powder Free Vinyl Examination Gloves	General Gloves Corp.	LYZ	Class I	2003-01-28
K024081	Disposble Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color	Safehealth Medical Supply Corp.	LYZ	Class I	2003-01-28
K023935	Trilumina Therapeutic Laser System	Texas Applied Biomedical Services	NHN	Class II	2003-01-28
K023901	Alumina V40 Femoral Heads	Howmedica Osteonics Corp	LZO	Class II	2003-01-28
K023851	Precimed Hip Screw System	Precimed, Inc.	KTT	Class II	2003-01-28
K023802	Synthes 4.5 Mm Titanium Lcp Proximal Tibia Plating System	Synthes (USA) Products LLC	HRS	Class II	2003-01-28
K023764	Unicel Dxi 800 Access Immunoassay System, Model 973100	Siemens Healthcare Diagnostics Inc.	JJE	Class I	2003-01-28
K023579	Gas Sampling Lines	Promedic, Inc.	CCK	Class II	2003-01-28
K023070	Sodem High Speed System (Pneumatic)	Sodemsystems	ERL	Class II	2003-01-28
K023004	Lfre Indirect Laryngoscope	Astralite Corp.	EOB	Class II	2003-01-28
K022846	Sw-180 Shortwave Therapy Unit	Ito Co., Ltd.	IMJ	Class II	2003-01-28
K021963	Biosorb Resorbable Void Filler	Sciences et Bio Materiaux (Sbm)	MQV	Class II	2003-01-28
K030002	Lifeshield Primary IV Set Conv. Pin. Clave; Lf Lc 5000 Plumset-Dual W/conv Pin & Cap Port; Lifeshield Lf Macrobore Ext.	Abbott Medical	FPA	Class II	2003-01-27
K024101	Phoenix Universal Shunt System	Phoenix Biomedical Corp.	JXG	Class II	2003-01-27
K024040	Accura Elite Shunt System	Phoenix Biomedical Corp.	JXG	Class II	2003-01-27
K023971	Vacuette Trace Elements Tubes	Greiner Bio-One Vacuette North America	JKA	Class II	2003-01-27
K023967	Palomar Q-Yag Nd:yag Laser System	Palomar Medical Technologies, Inc.	GEX	Class II	2003-01-27
K023624	Slt Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921	Surgical Laser Technologies, Inc.	GEX	Class II	2003-01-27
K023254	Speedicath	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2003-01-27
K022951	Candela Gentle Yag Laser System, Variable Pulse Yag	Candela Corporation	GEX	Class II	2003-01-27
K022929	Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart AED, Model 9200/9210	ZOLL Medical Corporation	MKJ	Class III	2003-01-27
K022366	Celsius Control System	Innercool Therapies	NCX	Class II	2003-01-27
K022360	Era 3000; Pa-2 Is-1 Adapter; Ek-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); Nk-11 Power Supp.	BIOTRONIK AG	DTA	Class II	2003-01-27
K022341	Terabyte 2000 Hair Remover	Terabyte Co.	GEX	Class II	2003-01-27
K021750	Lid Chain Eyelid Weights	JEDMED Instrument Company	MML	Class II	2003-01-27
K020892	Acist Gentoo Contrast Injection System	Acist Medical Systems, Inc.	DXT	Class II	2003-01-27
K030179	Medisiss Phacoemulsification Tips/needles	Surgical Instruments Service and Savings, Inc.	NKX	Class II	2003-01-24
K030102	Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3	Medrad, Inc.	JJT	Class I	2003-01-24
K030090	H2 Heated Humidifier	Respironics, Inc.	BTT	Class II	2003-01-24
K030078	Burbank Tenaculum, Model 09-0011-01	Vascular Control Systems, Inc.	HDC	Class II	2003-01-24
K030019	Modification to Hi-Torque Whisper Guidewire	Boston Scientific Corporation	DQX	Class II	2003-01-24
K024103	Ivus Plus	Indec Systems, Inc.	LLZ	Class II	2003-01-24
K024028	Sharp View Image Enhancement System	Context Vision AB	LLZ	Class II	2003-01-24
K024021	Nitrex Nitinol Guidewire	Medtronic, Inc.	DQX	Class II	2003-01-24
K023979	Nitrile Examination Gloves, Pre-Powdered	Starmatrix Sdn Bhd	LZA	Class I	2003-01-24
K023978	Nitrile Examination Gloves, Powder Free	Starmatrix Sdn Bhd	LZA	Class I	2003-01-24
K023977	Pre-Powdered Latex Examination Gloves, with Protein Labeling Claim	Starmatrix Sdn Bhd	LYY	Class I	2003-01-24
K023970	Quantitative Vascular Angiography - Cms	Medis Medical Imaging Systems, B.V.	IZI	Class II	2003-01-24
K023878	Guardwire Temporary Occlusion and Aspiration System	Medtronic, Inc.	NFA	Class II	2003-01-24