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 2307 of 3531

510(k) clearances, page 2307 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924761	Sterile Endoscopic Dispos Trocars W/safe Shield	Richard-Allan Medical Ind., Inc.	GCJ	Class II	1993-04-20
K924501	Gillam-Tukel Bone Marrow Biopsy Needle	Boston Scientific Corporation	GAA	Class I	1993-04-20
K923662	Ingrown Toenail Pad	Many Bee Co.	KGX	Class I	1993-04-20
K923068	Avi Model 3100 Infusion Pump	3M Company	FRN	Class II	1993-04-20
K921899	Interlink System - T-Connector Extension Set	Baxter Healthcare Corporation	FPA	Class II	1993-04-20
K921471	Burnshield Trauma Dressing	Levtrade Intl. (Pty), Ltd.	FPY	Class I	1993-04-20
K921470	Burnshield Fire Blanket	Levtrade Intl. (Pty), Ltd.	FPY	Class I	1993-04-20
K920851	Macview	Dimensional Medicine, Inc.	LLZ	Class II	1993-04-20
K920611	Marlow Laparoscopic Grasping Forcep	Marlo Surgical Technology	GCJ	Class II	1993-04-20
K920262	Onat Ballooned Nasogastric Tube	Macdonald Medical Devices, Inc.	KNT	Class II	1993-04-20
K913566	Arthroscopic Lumbar Mechanical and Laser Discectom	Alfred O. Bonati, M.D.	GEX	Class II	1993-04-20
K925781	Disposable Cuffed Endotracheal Tube	Coast Medical Corp.	BTR	Class II	1993-04-19
K925424	Medical Manufacturing Inc Gas Sampling Lines&conn.	Medical Manufacturers	CCK	Class II	1993-04-19
K925386	Adhesive E.t. Tape	B & B Medical Technologies, Inc.	CBH	Class I	1993-04-19
K925281	Kit Pak Urinary Care Supplies	Kit Pak, Inc.	KNY	Class II	1993-04-19
K925014	E-Sp Combined Epi Spinal Miniset	Neuro Technology	CAZ	Class II	1993-04-19
K930690	Stc Diagnostics Auto-Lyte Amphetamines Eia	Solarcare Technologies Corp,Inc.	DKZ	Class II	1993-04-16
K930258	Tracet T-6000	Lectec Corp.	DRX	Class II	1993-04-16
K924960	Excalibur Electrosurgical Unit	Aspen Laboratories, Inc.	GEI	Class II	1993-04-16
K930222	Camino Ventricular Access Device	Camino Laboratories, Inc.	JXG	Class II	1993-04-15
K930221	Camino Ventricular Transducer Accessory	Camino Laboratories, Inc.	GWM	Class II	1993-04-15
K926175	K-Defib/pace Carbon Electrode	Katecho LLC	DRO	Class II	1993-04-15
K925876	Itc Bunji Platinum Embolization Coil	Interventional Therapeutics Corp.	HCG	Class II	1993-04-15
K925266	Surepen(tm) Disposable Active Electrodes	Laser Surgical Systems	GEI	Class II	1993-04-15
K924664	Surgilase Fiberlase CO2 Laser Waveguide	Surgilase, Inc.	GEX	Class II	1993-04-15
K923003	Pajunk Standard Sprotte Needle W/ Introducer Cann.	Rusch, Inc.	BSP	Class II	1993-04-15
K922880	Xomed Treace Jet Ventilation Tube	Xomed-Treace, Inc.	BTR	Class II	1993-04-15
K915663	TENS Pro 900	Acuhealth (USA) Pty., Ltd.	GZJ	Class II	1993-04-15
K931158	Memorex Model 361-Agco Hearing Aid	Telex Communications, Inc.	ESD	Class I	1993-04-14
K931157	Behind-the-Ear Hearing Aid, Telex Model 380-Pp	Telex Communications, Inc.	ESD	Class I	1993-04-14
K931134	Behind-the-Ear Hearing Aid, Telex Model 361-Pp	Telex Communications, Inc.	ESD	Class I	1993-04-14
K926247	Omron Travel Toothbrush/plaque Remover #Ht-B005	Omron Healthcare Co., Ltd.	JEQ	Class I	1993-04-14
K926246	Omron Rechargeable Plaque Removal System #Ht-B142	Omron Healthcare Co., Ltd.	JEQ	Class I	1993-04-14
K925780	Branemark System Healing Caps	Nobelpharma USA, Inc.	DZE	Class II	1993-04-14
K925778	Branemark System Lab. and Educational Accessories	Nobelpharma USA, Inc.	DZE	Class II	1993-04-14
K925777	Branemark System Estheticone Abutment Complete	Nobelpharma USA, Inc.	DZE	Class II	1993-04-14
K925773	Branemark System Gold Cylinders and Screws	Nobelpharma USA, Inc.	DZE	Class II	1993-04-14
K925771	Branemark System Titanium Cover Screws	Nobelpharma USA, Inc.	DZE	Class II	1993-04-14
K925769	Branemark System Abutments Complete	Nobelpharma USA, Inc.	NHA	Class II	1993-04-14
K925677	Autochill Accessory Kit	Aircast, Inc.	ILO	Class II	1993-04-14
K925500	Alphatec 130 Compression Hip Screw	Alphatec Spine, Inc.	HRS	Class II	1993-04-14
K924786	Burton Trial Lens Set	R.H. Burton Co.	HPC	Class I	1993-04-14
K924783	Burton Slit Lamp - Model 850	R.H. Burton Co.	HJO	Class II	1993-04-14
K924774	Burton Automatic Projector - Model Cp-40	R.H. Burton Co.	HOD	Class I	1993-04-14
K924288	B1018 Porous Ha Bii-Pore	Bio-Interfaces, Inc.	LYC	Class II	1993-04-14
K924286	4060 Porous Ha Particules Bii Pore	Bio-Interfaces, Inc.	LYC	Class II	1993-04-14
K924135	Flexible Ureteronephrosocope	Applied Medical Resources Corp	FEB	Class II	1993-04-14
K924023	Ferno Ille Inferno Moist Heat Therapy Ut, 916/917	Ferno	IRQ	Class I	1993-04-14
K923911	Intrinsic Stem	Turnkey Intergration USA, Inc.	LWJ	Class II	1993-04-14
K923627	Cold Pack	Friendmed Products	IME	Class I	1993-04-14