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 943 of 3531

510(k) clearances, page 943 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K112385	Traget Detachable Coil	Stryker Corp.	HCG	Class II	2011-09-15
K112372	Cardiosave Hybrid Intra-Aortic Balloon Pump	Cardiac Assist, Maquet Cardiovascular, LLC	DSP	Class II	2011-09-15
K112366	4Ch Flex Speeder	Toshiba Medical Systems Coporation, Japan	MOS	Class II	2011-09-15
K112360	Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-Id Diffusion Membrane Oxygenators Series	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2011-09-15
K112176	Silicone Spheres	Oculo Plastik, Inc.	HPZ	Class II	2011-09-15
K112075	Vitek 2 Strptococcus Ampicillin	bioMerieux, Inc.	LON	Class II	2011-09-15
K112025	Sure Lok Mini Posterior Cervical/upper Thoracic System	Spinal USA	KWP	Class II	2011-09-15
K111966	Proclear, Proclear Toric, Proclear Multifocal, Proclear 1Day, Proclear Xc	CooperVision, Inc.	LPL	Class II	2011-09-15
K111767	Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit	Ness-Neuromuscular Electrical Stimulation Systems	GZI	Class II	2011-09-15
K111763	Pathassist Light Fiber	Entellus Medical, Inc.	LRC	Class I	2011-09-15
K111731	Molecular Breast Imaging Software	Gamma Medica-Ideas Incorporated	LLZ	Class II	2011-09-15
K111694	Astra	Candelis, Inc.	LLZ	Class II	2011-09-15
K111510	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2011-09-15
K111457	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2011-09-15
K111003	Biodenta Dental Implant System - Bone Level	Biodenta Swiss AG	DZE	Class II	2011-09-15
K110766	Kolplux System	Kolplast Ci Ltda	HIB	Class II	2011-09-15
K110370	Q-Clear	Light Age, Inc.	PDZ	Class II	2011-09-15
K110033	Feel-Drcs	Imfou Co., Ltd.	LLZ	Class II	2011-09-15
K103639	Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)- Pediatric	Vortran Medical Technology 1, Inc	CAP	Class II	2011-09-15
K103515	Equal Dose	Nucletron BV	MUJ	Class II	2011-09-15
K103089	Seven Implants; Biocom Implants; Lance Implants	Mis - Implant Technologies, Ltd.	DZE	Class II	2011-09-15
K102816	Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips	Apex Biotechnology Corp.	NBW	Class II	2011-09-15
K101898	R4 Acert Ultrasound Reporting System	R4, LLC	LLZ	Class II	2011-09-15
K112465	Vital Signs Monitor	Advanced Instruments, LLC	DQA	Class II	2011-09-14
K112198	Expect Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	ODG	Class II	2011-09-14
K112196	Octotmport	Dalim Surgnet Corporation	OTJ	Class II	2011-09-14
K112113	Elecsys Myoglobin Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-09-14
K111996	Elitech Clinical Sysems Ise Control 1 and 2	ELITechGroup Inc	JJY	Class I	2011-09-14
K111814	Padlock	Reliance Orthodontic Products, Inc.	DYH	Class II	2011-09-14
K111743	The Insync Ceramic System	Jensen Industries, Inc.	EIH	Class II	2011-09-14
K111612	Digital Retinal Camera	Canon, Inc.	HKI	Class II	2011-09-14
K111360	Sheaumann Pl-980	Sheaumann Lasers	GEX	Class II	2011-09-14
K111322	Chemtrue Single/multi-Panel Drug Screen Cassette/dipcard	Chemtron Biotech, Inc.	JXM	Class II	2011-09-14
K110309	Fob One Step Rapid Test	Orient Gene Biotech	KHE	Class II	2011-09-14
K103810	Kj Submerged System	KJ Meditech Co., Ltd.	DZE	Class II	2011-09-14
K103648	Collagen Powder	Innocoll Pharmaceuticals	KGN	Unclassified	2011-09-14
K103426	Lite Pelvic Floor Repair Kits	Boston Scientific Corporation	OTP	Class III	2011-09-14
K112047	Amcom Commtech Messenger	Amcom Software,Inc.	MSX	Class II	2011-09-13
K112031	Alma Lasers Modified Diode Laser Module with Shr Treatment Mode for Use with the Family of Soprano Xl Multi-Application	Alma Lasers Ltd.	GEX	Class II	2011-09-13
K111778	Jbaids Influenza a Subtyping Kit	U.S Army Medical Materiel Development Activity	OQW	Class II	2011-09-13
K111775	Jbaids Influenza A&b Detection Kit	U.S. Army Medical Material Development Acitvity	OCC	Class II	2011-09-13
K111660	Xelis Cardiac	Infinitt Co., Ltd.	LLZ	Class II	2011-09-13
K111359	Sheaumann Pl-1064	Sheaumann Lasers	GEX	Class II	2011-09-13
K111270	Reusable Stimulating Electrodes	Bio Protech, Inc.	GXY	Class II	2011-09-13
K111115	Captiva Spine Caplox II Spinal Fixation System	CAPTIVA SPINE, Inc.	MNI	Class II	2011-09-13
K110945	Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves	Zhaoyang Plastic Co., Ltd.	LYZ	Class I	2011-09-13
K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular Inc.	DQY	Class II	2011-09-13
K110659	Medical Concepts Interbody Fusion System	Medical Concepts	MAX	Class II	2011-09-13
K103461	Colgate Desensitizing Dental Cream	Colgate-Palmolive Company	LBH	Class II	2011-09-13
K102483	Sunset Healthcare Solutions Bacterial/viral Hme Filter, Model Bhf 104	SUNSET HEALTHCARE SOLUTIONS, Inc.	CAH	Class II	2011-09-13