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 1346 of 3531

510(k) clearances, page 1346 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050143	Omnipro System	Mays and Associates, Inc.	OLV	Class II	2005-02-01
K050102	E-Z Pen, Reuseable Handswitching Pencil	Megadyne Medical Products, Inc	GEI	Class II	2005-02-01
K050087	Lerado Avanticare Power Wheelchair, Model Pw-1800	Lerado Oversea Ltd. Twn Branch (Bvi)	ITI	Class II	2005-02-01
K050067	Femtex and Private Label Scented Plastic Applicator Tampons	First Quality Hygienic, Inc.	HIL	Class II	2005-02-01
K043540	Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses	Westcon Contact Lens Co., Inc.	LPL	Class II	2005-02-01
K043475	Powder-Free Vinyl Patient Examination Gloves, White (Non-Colored)	Shijiazhuang Winful Plastic Co., Ltd.	LYZ	Class I	2005-02-01
K043423	Model Sc-3008 Sequential Circulator	Bio Compression Systems, Inc.	JOW	Class II	2005-02-01
K043368	Vitelcare Turtle, Model 400	Visual Telecommunications Network, Inc.	MWI	Class II	2005-02-01
K043323	D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/cardiotomy Reservoir	Dideco S.p.A.	DTZ	Class II	2005-02-01
K043312	Nobelrondo Dental Ceramic - Zirconia	Nobel Biocare USA LLC	EIH	Class II	2005-02-01
K043233	Gotfried Physiological Hip (Ph) Nail	Efratgo, Ltd. HI Tech Bio-Surgical	HSB	Class II	2005-02-01
K043168	Biscover Lv	Bisco Inc	EBD	Class II	2005-02-01
K043152	Vertebron Pss Pedicle Screw System	Vertebron, Inc.	MNH	Class II	2005-02-01
K043151	Modification to: Cd Horizon Spinal System	Medtronic Sofamor Danek	KWQ	Class II	2005-02-01
K043046	Cooltouch, Model Ct3s	New Star Lasers, Inc.	GEX	Class II	2005-02-01
K042804	Tescera Opaquer Powder/sculpting Resin	Bisco Inc	EBF	Class II	2005-02-01
K042531	Updated Slip Urology Introducer Sheath	Percutaneous Systems, Incorporated	KNY	Class II	2005-02-01
K031782	Gapp Graft Contianment Device Orthopedics	Medtronic Sofamor Danek	KWQ	Class II	2005-02-01
K050121	Zimmer Periarticular Locking Plate System, Model 2357 & 2359	Zimmer GmbH	HRS	Class II	2005-01-31
K050092	R605 Facs Collimeter	Omega Medical Imaging, LLC	IZW	Class II	2005-01-31
K050069	Cutera Flashlamp Tabletop Aesthetic Product	Cutera Inc	GEX	Class II	2005-01-31
K050049	Dynaflo Bypass Graft	Bard Peripheral Vascular Inc	DSY	Class II	2005-01-31
K050026	Precinorm Proteins in Urine/csf (Puc) and Precipath Puc	Roche Diagnostics GmbH	JIX	Class II	2005-01-31
K050019	In Exam Intraoral Dental X-Ray System	Kavo America	EHD	Class II	2005-01-31
K043460	Olympus Lyophilized Chemistry Calibrators Dr0070 and Dr0071	OLYMPUS Corporation of the Americas	JIX	Class II	2005-01-31
K043346	Genesis Total Shoulder Replacement, Model 100-01-00	Genesis Medical LLC	KWS	Class II	2005-01-31
K043270	Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series	Zimmer GmbH	HSB	Class II	2005-01-31
K043173	Q-Switched Nd:yag Laser Treatment Head for the Lumenis Quantum Series	Lumenis Ltd	GEX	Class II	2005-01-31
K043150	Amadeus II Epikeratome	Sis Ltd., Surgical Instrument Systems	HNO	Class I	2005-01-31
K042937	Modification to Vascular Solutions Pronto Extraction Catheter	Vascular Solutions LLC	QEZ	Class II	2005-01-31
K042794	Beam Modulator, Model 4513 332 8000	Elekta Limited	IYE	Class II	2005-01-31
K041630	Orbital Atherectomy System for Treatment of a-V Shunt Stenosis	Cardiovascular Systems Incorporated	MCW	Class II	2005-01-31
K050099	Sigma 5000 Series Imagic Ultrasound System	Kontron Medical Systems SAS	IYN	Class II	2005-01-28
K043607	BIPAP Pro 2 Bi-Level System with Bi-Flex	Respironics, Inc.	BZD	Class II	2005-01-28
K043504	Palaimpact	Kulzer GmbH	EBI	Class II	2005-01-28
K043487	Evis Exera Colonovideoscope Model Xcf-Q160w1l/1	Aizu Olympus Co., Ltd.	FDF	Class II	2005-01-28
K043483	Radin, Model V 3.0	Sohard AG	LLZ	Class II	2005-01-28
K043430	20.8-Inch (53 Cm) Color Lcd Monitor, Models Cdl2114a and Dv3mc-Hb	Totoku Electric Co., Ltd.	LLZ	Class II	2005-01-28
K043290	Mindstate Functional Data Acquisition Device, Version 1.0	Neurognostics, Inc.	LNH	Class II	2005-01-28
K043274	Neuromonics Tinnitus Treatment	Neuromonics Pty, Ltd.	KLW	Class II	2005-01-28
K043014	Powder Free Natural Rubber Latex Patient Examination Gloves with Labeling Protein Content Claim (50 Micrograms or Less)	Shijiazhuang Tillotson Rubber Products Co., Ltd.	LYY	Class I	2005-01-28
K042321	Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head	Biomet Manufacturing Corp	KWT	Class II	2005-01-28
K042278	Oral Osteodistraction Rod Appliance (Rod 5)	Oral Osteodistraction, L.P.	MQN	Class II	2005-01-28
K042112	Infant Feeding Tube	Marian Medical, Inc.	KNT	Class II	2005-01-28
K041992	Medtronic Stratavarius	Medtronic Neurosurgery	JXG	Class II	2005-01-28
K041841	Pachycam	Oculus Optikgerate GmbH	MXK	Class II	2005-01-28
K050027	Laparocision Scope Controller System	Gmp/Companies, Inc.	GCJ	Class II	2005-01-27
K043564	Horizon Angio Cathlab	Mennen Medical, Inc.	DQK	Class II	2005-01-27
K043550	Amplife Upper Arm Blood Pressure Monitor, Model M100	Amplife Corporation	DXN	Class II	2005-01-27
K043471	Fusion Fast	GC America Inc.	ELW	Class II	2005-01-27