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 1417 of 3531

510(k) clearances, page 1417 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032796	Ibl C3d-Cic Eia Test	Ibl GmbH	CZW	Class II	2004-01-13
K023506	Surgical Medical Device Cautery	Modern Medical Equipment Mfg., Ltd.	HQP	Class II	2004-01-13
K033929	Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	DQX	Class II	2004-01-12
K033742	Boston Scientific V-18 Control Wire	Boston Scientific Corporation	DQX	Class II	2004-01-12
K033525	Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models Df114, Dc114	Siemens Healthcare Diagnostics Inc.	DCF	Class II	2004-01-12
K033414	Acl Top Model, Top	Instrumentation Laboratory Co.	GKP	Class II	2004-01-12
K033391	Medical Maggots	Ronald A. Sherman	NQK	Unclassified	2004-01-12
K033286	Odi Talon Long Proximal Femoral Nail System	Orthopedic Designs, Inc. (Odi)	HSB	Class II	2004-01-12
K033155	Biocentrex Cardiac Panel	Biocentrex	MYT	Class II	2004-01-12
K032361	Endopure Root Canal Cleanser	Dentsply Intl.	KJJ	Unclassified	2004-01-12
K032334	Roche Online Tdm Lidocaine	Roche Diagnostics GmbH	KLR	Class II	2004-01-12
K032332	Roche Online Tdm Quinidine	Roche Diagnostics GmbH	LBZ	Class II	2004-01-12
K031147	Optical Dvs (Dual Vector Shearing) Esophageal Dilator	Ethicon Endo-Surgery Inc	KNQ	Class II	2004-01-12
K033830	Option-Vf Urinary Catheter with Adaptor, Model Fva14218; Option-V Continuous Drainage Adaptor, Model Cda1000	Opticon Medical, Inc.	EZL	Class II	2004-01-09
K033490	Spirit 5000 Cardiac Coil	GE Healthcare Coils	MOS	Class II	2004-01-09
K033377	Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and Fm-Dp L	FUJIFILM Healthcare Americas Corporation	LMC	Class II	2004-01-09
K033372	Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models	Medtronic, Inc.	HCG	Class II	2004-01-09
K033357	Acqsim-Multislice-CT, Model 453567042271	Philips North America LLC	JAK	Class II	2004-01-09
K033215	Prepair	Danville Materials, Inc.	KOJ	Class II	2004-01-09
K032886	Diamond Setup 2000	K&S Assoc., Inc.	LHN	Class II	2004-01-09
K032710	Closed System Intermittent Catheterization Kit	Robling Medical, LLC	KOD	Class II	2004-01-09
K032585	Transvaginal Ultrasound Probe Holder System	Ron-Tech Medical, Ltd.	HDC	Class II	2004-01-09
K032051	Battery Pack, Rechargeable, Models Mla0051, Mla90479, Mnc5169l/p, Mnc1000ekg, Mnc14649p	Access Battery, Inc.	MKJ	Class III	2004-01-09
K034013	Reaads Dsdna Quantitative Test Kit, Model 022-001	Corgenix, Inc.	LKJ	Class II	2004-01-08
K034003	Hdi 5000 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2004-01-08
K033987	D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters	Dideco S.p.A.	DTM	Class II	2004-01-08
K033845	Precision Xceed Diabetes Monitoring System	Abbott Medical	NBW	Class II	2004-01-08
K033837	Stryker Spine Vertebral Body Support System	Howmedica Osteonics Corp	MQP	Class II	2004-01-08
K033818	Microlife Digital Infrared Ear Thermometer, Models Ir1dc1/v971, Ir1dg1/sku4289, Ir1dh1/sku4290	Microlife Intellectual Property GmbH	FLL	Class II	2004-01-08
K033817	Microlife Digital Infrared Ear Thermometer, Models Ir1da1-2, Ir1de1-2	Microlife Intellectual Property GmbH	FLL	Class II	2004-01-08
K033683	Smart-Feel Powder Free Nitrile Examination Gloves Pink Color	Smart Glove Corp. Sdn Bhd	LZA	Class I	2004-01-08
K033643	CO2 Calibrator/diluent	Bayer Healthcare, Diagnostics Division	JIT	Class II	2004-01-08
K033539	Disposal Powder Free Vinyl Synthetic Examination Gloves, Green Color	Shen Wei (USA), Inc.	LYZ	Class I	2004-01-08
K033338	Pinnacle Revision System	Depuy Orthopaedics Inc.	LPH	Class II	2004-01-08
K032822	Asap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0	asap endoscopic products GmbH	EOB	Class II	2004-01-08
K032126	Promos Shoulder	Plus Orthopedics	HSD	Class II	2004-01-08
K031962	Nexgen Trabecular Metal Tibial Cone Augments	Implex Corp.	JWH	Class II	2004-01-08
K031715	Ariol Her-2/Neu Ihc	Applied Imaging Corp.	NOT	Class II	2004-01-08
K033937	Elecsys Precicontrol Multianalyte	Roche Diagnostics GmbH	JJY	Class I	2004-01-07
K033922	Modification to Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2004-01-07
K033660	Storz Raney Scalp Clip, Model 1-20-004-05	Rudolf Storz GmbH	HBO	Class II	2004-01-07
K033547	Vnus Vessel and Tissue Coagulation System	Vnus Medical Technologies, Inc.	GEI	Class II	2004-01-07
K033535	Lumend Frontrunner Cto Catheter and Accessories	Lumend, Inc.	PDU	Class II	2004-01-07
K033475	Wireless Input Unit, Model Wee-1000A Series	Nihon Kohden America Inc	OLV	Class II	2004-01-07
K033469	Genesis Vertical Platform Lift	Garaventa Accessibility	ING	Class II	2004-01-07
K033449	Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices	Professional Dental Technologies Therapeutics, Inc.	EJR	Class I	2004-01-07
K033413	Spineassist Device	Mazor Surgical Technologies, Ltd.	HAW	Class II	2004-01-07
K033268	Sea-Band	Sea-Band UK, Ltd.	MVV	Unclassified	2004-01-07
K032031	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	DQX	Class II	2004-01-07
K032003	Premier Plus	American Imex	GZJ	Class II	2004-01-07