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 2026-11-02, 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 965 of 3531

510(k) clearances, page 965 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103112	Affymetrix Gene Profiling Reagents	Affymetrix Inc	OVA	Class II	2011-05-04
K102922	Hardychrom Mrsa	Hardy Diagnostics	JSO	Class II	2011-05-04
K102681	Advia Centaur Toxoplasma Igg (Toxo G)	Siemens Healthcare Diagnostics Inc.	LGD	Class II	2011-05-04
K102324	Endofuse Intra-Osseous Fusion System	Wrightmedicaltechnologyinc	HWC	Class II	2011-05-04
K102307	Genoss Collagen Membrane Model Gcm1020, Gcm3040 Total 6 Models	GENOSS Co., Ltd.	NPL	Class II	2011-05-04
K111056	Piccolo Composite Nailing System	CarboFix Orthopedics Inc.	HSB	Class II	2011-05-03
K110985	Icon Adult Manual	Icon Wheelchairs, Inc.	IOR	Class I	2011-05-03
K110976	Origen Dbm with Bioactive Glass, Nanofuse Dbm	Nanotherapeutics	MQV	Class II	2011-05-03
K110932	Tinnitus Sound Generator Module	GN Resound A/S	KLW	Class II	2011-05-03
K110620	Premier C. Difficile Gdh	Meridian Bioscience Inc	MCB	Class I	2011-05-03
K110573	Ready View	GE Healthcare (GE Medical Systems Scs)	LLZ	Class II	2011-05-03
K110446	Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid	Roche Diagnostics GmbH	DKZ	Class II	2011-05-03
K110384	Dilon 6800 Acella (Acella)	Dilon Technologies Inc	IYX	Class I	2011-05-03
K110349	Clear+brilliant Laser System	Solta Medical, Inc.	ONG	Class II	2011-05-03
K110087	Corin Trinity Acetbular System with Hxlpe Liners	Corin USA	LZO	Class II	2011-05-03
K110039	Biomet Sports Medicine Sternal Closure System	Biomet Sports Medicine	JDQ	Class II	2011-05-03
K102843	Mac Male Adapter	Biomet Trauma (Aka Ebi, LP)	KTT	Class II	2011-05-03
K103793	Durafiber Ag	Smith & Nephew, Inc.	FRO	Unclassified	2011-05-02
K102191	Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;transtek Glass Body Analyzer	Zhongshan Transtek Electronics Co., Ltd	MNW	Class II	2011-05-02
K101991	Webster Duo-Decapolar Catheter	Biosense Webster Inc	DRF	Class II	2011-05-02
K110909	Emboshield Nav6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190Cm / 315Cm, Barewire Filter Del..	Abbott Medical	NTE	Class II	2011-04-29
K110903	Pts-X Sizing Balloon Catheter	Numed Inc	MJN	Class II	2011-04-29
K110561	Fortross Bone Void Filler	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2011-04-29
K110455	Kimberly-Clark Low Barrier, ASTM 2100 Face Masks	Kimberly-Clark Corporation	FXX	Class II	2011-04-29
K110266	Mac 5500 Hd, Mac 3500	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2011-04-29
K110253	Reusable Test Pack for Dana Emulating Indicators	Dana Products, Inc.	JOJ	Class II	2011-04-29
K110037	Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid	Kulzer GmbH	EBI	Class II	2011-04-29
K103343	L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)	Bioness, Inc.	GZI	Class II	2011-04-29
K103196	Powder-Free Vinyl Patient Examination Gloves	Changda Plastic Product Co., Ltd.	LYZ	Class I	2011-04-29
K101348	Agachamber Spacer	Aga Plastic Ind. Com. Ltda.	NVP	Class II	2011-04-29
K093640	Digital X-Ray Detectors Family Krc and Dira	Electron Jsco.	IXK	Class II	2011-04-29
K110911	Renaissance System	Mazor Robotics Ltd	HAW	Class II	2011-04-28
K110772	Biomarc Fiducial Marker	Carbon Medical Technologies, Inc.	IYE	Class II	2011-04-28
K110750	Periopatch	MIS Implants Technologies Ltd.	OLR	Unclassified	2011-04-28
K110582	Valo Cordless	Ultradent Products Inc.	EBZ	Class II	2011-04-28
K110288	Femvue Saline-Air Device	Femasys Inc.	LKF	Class II	2011-04-28
K110286	Gn Otometrics Type 1053 Freefit	Natus Medical Denmark ApS	ETW	Class II	2011-04-28
K110123	Pcl Tightrope	Arthrex GmbH	HTY	Class II	2011-04-28
K110105	Bd Pen Needle	Becton, Dickinson & Company (BD)	FMI	Class II	2011-04-28
K110025	Sectra Microdose Mammography	Sectra-Imtec AB	MUE	Class II	2011-04-28
K103758	Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10	Terumo Cardiovascular Systems Corporation	HCG	Class II	2011-04-28
K103683	Immulite/immulite 1000 Progesterone Calibration Verification (Cvm)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2011-04-28
K103455	Spectra Laser System	Lutronic Corporation	GEX	Class II	2011-04-28
K102957	Cutting Edge Spine Interbody Fusion Device	Cutting Edge Spine	MAX	Class II	2011-04-28
K102895	One Day Flat Pack	Menicon Co. Ltd.	LPL	Class II	2011-04-28
K102481	Autosure Voice 3 Blood Glucose Monitoring System and Test Strip	Apex Biotechnology Corp.	NBW	Class II	2011-04-28
K102152	Powder-Free Vinyl Patient Examination Gloves	Hebei Tengda Plastic Co., Ltd.	LYZ	Class I	2011-04-28
K101578	R&d Systems Body Fluid-I Hematology Control	R & D Systems, Inc.	JPK	Class II	2011-04-28
K111021	Cubescan / Biocon-700	MCUBE TECHNOLOGY Co.,Ltd.	ITX	Class II	2011-04-27
K110865	Aequalis Ascend Modular Anatomic Shoulder System	TORNIER Inc.	KWS	Class II	2011-04-27