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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 903 of 3530

510(k) clearances, page 903 of 3530
K number	Device	Applicant	Product code	Class	Decision date
DEN100016	Prostate Mechanical Imager	Artann Laboratories, Inc.	OQT	Class II	2012-04-27
K121070	C-Qur Rpm Mesh	Atrium Medical Corporation	FTL	Class II	2012-04-26
K120939	Aeroneb Pro	Aerogen Ltd.	CAF	Class II	2012-04-26
K120517	Depuy Pulse Cervical Cage System	Medos International SARL	ODP	Class II	2012-04-26
K120437	Twister Side-Fire Fiber Optic Delivery System	Biolitec SIA (Latvia)	GEX	Class II	2012-04-26
K113796	Solitaire-C Cervical Spacer System	Ebi, LLC	OVE	Class II	2012-04-26
K112342	Flexi-Seal Signal Fecal Management System	ConvaTec Limited	KNT	Class II	2012-04-26
K112153	Iroot 100 Mini	S-Denti Co., Ltd.	LQY	Unclassified	2012-04-26
K110835	Geo Magic Color (Polymacon) Soft (Hydrophilic) Contact Lens	Geo Medical Co., Ltd	LPL	Class II	2012-04-26
K120979	Carefusion Nicolet Edx	Medtronic, Inc.	GWF	Class II	2012-04-25
K120908	Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2012-04-25
K113760	Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick	Howmedica Osteonics Corp., dba Stryker Orthopaedics	HRS	Class II	2012-04-25
K113585	Nasal/epistaxis Pack	Cogent Therapeutics, LLC	LYA	Class I	2012-04-25
K113485	Electrocardiograph	Shenzhen Carewell Electronics Co., Ltd.	DPS	Class II	2012-04-25
K112761	Zoll Propaq Md	ZOLL Medical Corporation	MKJ	Class III	2012-04-25
K112611	Sintea Plustek Pls Multi-Axial Screws	Sintea Plastek, LLC	MNI	Class II	2012-04-25
K111085	Sharps Tank Reusable Sharps Container	Rehrig Pacific Company	MMK	Class II	2012-04-25
K121004	Apex Kirschner Wires and Steinmann Pins	Apex Tools & Orthopedics Co.	HTY	Class II	2012-04-24
K120757	Sleepweaver Elan Nasal CPAP Mask	Circadiance	BZD	Class II	2012-04-24
K120664	Piccolo Trglycerides-Capillary Test System	Abaxis Inc	JGY	Class I	2012-04-24
K120662	Piccolo Hdl-Capillary Test System	Abaxis Inc	JHM	Class I	2012-04-24
K120645	Pro-Toe(tm) Vo Hamertoe Implant System-Line Sddition	Wrightmedicaltechnologyinc	HWC	Class II	2012-04-24
K120589	Milagro Interference Screws	DePuy Mitek, Inc.	MAI	Class II	2012-04-24
K120452	Flexstent Biliary Self-Expanding Stent System	Flexible Stenting Solutions, Inc.	FGE	Class II	2012-04-24
K120231	Evolve Hpd 980/ 1470Nm Multiwavelength Diode Laser (Evolve Dual)	Biolitec Medical Devices, Inc.	GEX	Class II	2012-04-24
K120086	Cariosolutions Percu-Pro Steerable Introdcer 65Cm Cariosolutions Percu-Pro Steerable Introducer 80Cm	Cardiosolutions, Inc.	DRA	Class II	2012-04-24
K120055	Hanilton Thorne Infrared Laser Optical System-Zilos-Tk Hamilton Thorne Infrared Laser Optical System-Lykos	HAMILTON THORNE, Inc.	MRX	Class II	2012-04-24
K120015	Osteomed Wrist Plating System	Osteomed	HRS	Class II	2012-04-24
K112734	Aplan A.v. Fistula Needle Set	Aplan Well Enterprise Co., Ltd.	FIE	Class II	2012-04-24
K112094	Brain Biopsy Needle	AD-Tech Medical Instrument Corp.	HAW	Class II	2012-04-24
K103230	Ap-3000 Blood Glucose Monitoring System, Major Glucose Control Solution	Bestgen Biotech Corp.	CGA	Class II	2012-04-24
K120207	Visia	Mevis Medical Solutions AG	LLZ	Class II	2012-04-23
K113857	Synergetics Directional Endoocular Laser Probe	Synergetics Inc	HQB	Class II	2012-04-23
K112315	Home Pregnancy Test	Newscen Coast Bio-Pharmaceutical Co., Ltd.	JHI	Class II	2012-04-23
K111824	Flat Panel Detector	Canon Inc. -Medical Equipment Group	MQB	Class II	2012-04-23
K120942	Parcus Twist 4 5Mm Peek Suture Anchor, Parcus Twist 5.5Mm Peek Suture Anchor & Parcus Triple Twist 5.5Mm Peek Suture Anc	Parcus Medical, L.L.C.	MBI	Class II	2012-04-20
K120872	Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps	Unomedical A/S Infusion Devices	FPA	Class II	2012-04-20
K120868	Mega(tm) 7.5Fr. 30Cc Intra-Aortic Balloon Catheter and Accessories, Mega(tm) 7.5Fr. 40Cc Intra-Aortic Balloon Catheter	Datascope Corp., Cardiac Assist Division	DSP	Class II	2012-04-20
K120853	Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,	Bioness, Inc.	GZI	Class II	2012-04-20
K120428	Gore Dryseal Sheath	W. L. Gore & Associates, Inc.	DYB	Class II	2012-04-20
K120313	Neo Cr Knee System	Pipeline Orthopedics	JWH	Class II	2012-04-20
K120208	Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2012-04-20
K120051	Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4Ml	Nephron SC, LLC.	CAF	Class II	2012-04-20
K120037	Bluwhite Diamond Dental Burs Modified	Beavers Dental, Div. Sybron Canada, Ltd.	DZP	Class I	2012-04-20
K113780	Easycare Tx System (Connexuns)	ResMed Corp	BZD	Class II	2012-04-20
K113778	Excelsior Xt-27 Microcatheter	Stryker Corp.	DQY	Class II	2012-04-20
K113719	Safety Screw Connector	Abbott Medical	KNT	Class II	2012-04-20
K113662	Fenestrated Nerve Block Needle	Imd, Inc.	CAZ	Class II	2012-04-20
K113633	Mckesson Anesthesia Care	Mckesson Technologies, Inc.	BSZ	Class II	2012-04-20
K113611	Rapid Programmer	Abbott Medical	GZB	Class II	2012-04-20