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 988 of 3531

510(k) clearances, page 988 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100451	Gamcath High Flow Dolphin Ms-Gdhc-1315 a; and Ms-Gdhc-1315J a, Gamcath High Flow Dolphin Ms-Gdhc-1320 a; and Ms-Gdhc-132	Gambro Renal Products	MPB	Class II	2010-12-21
K092844	Geosource	Electrical Geodesics, Inc.	OLX	Class II	2010-12-21
K103198	Powder-Free Vinyl Patient Examination Gloves	Youngshengplastic Co., Ltd.	LYZ	Class I	2010-12-20
K103189	Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck	Medacta International SA	LZO	Class II	2010-12-20
K103179	Prelude II Tounge Suspension System	Siesta Medical, Inc.	ORY	Class II	2010-12-20
K102981	Ace Freedom Internal Hexagon Dental Implant System	Ace Surgical Supply Co., Inc.	DZE	Class II	2010-12-20
K102977	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Heze Juxinyuan Food Co., Ltd.	LYZ	Class I	2010-12-20
K102969	Imc Piston Syringes	Intl. Medsurg Connection, Inc.	FMF	Class II	2010-12-20
K102889	Hitachi Echelon Nv Attachment and Small Extremity Coils Model Echelon	FUJIFILM Healthcare Americas Corporation	MOS	Class II	2010-12-20
K102875	Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; C	Integra LifeSciences Corporation	GWM	Class II	2010-12-20
K102777	Twistcut Endosorb Screws	Merete GmbH	JDW	Class II	2010-12-20
K102761	Dana Reusable Test Pack for Steam Sterilization	Dana Products, Inc.	JOJ	Class II	2010-12-20
K102724	Powder-Free Vinyl Patient Examination Gloves	Zibo Yuqun New Material Science and Technology Co	LYZ	Class I	2010-12-20
K102656	Synthes Dentoalveolar Bone Fixation System	Synthes (USA) Products LLC	JEY	Class II	2010-12-20
K102641	Mini and Micro Fragments Reconstruction System-Neoface	Neoortho Produtos Ortopedicos S/a	JEY	Class II	2010-12-20
K102593	Synthetic, Powder-Free Nitrile Examination	Zibo Yinghao Medical Products Co., Ltd.	LYZ	Class I	2010-12-20
K102180	Rhead Radial Head Extended Stems	Small Bone Innovations, Inc.	JDB	Class II	2010-12-20
K101870	Sunmax Vietnam Co. Ltd Powder Free White Nitrile Examination Glove	Sunmax Vietnam Co., Ltd.	LZA	Class I	2010-12-20
K101815	Enduro Knee System	Aesculap Inc	KRO	Class II	2010-12-20
K101278	Inertia Pedicle Screw System	Nexxt Spine LLC	MNH	Class II	2010-12-20
K100850	Cowell Implant System	Cowellmedi Co., Ltd.	DZE	Class II	2010-12-20
K093848	Pt-Multi-Calibrator, Model Opat07	Siemens Healthcare Diagnostics Inc.	GGN	Class II	2010-12-20
K093762	Synthes Zero-P	Synthes GmbH	OVE	Class II	2010-12-20
K090324	Ultrasight Hd Digital Colposcopy with Imagesense Technology	Sti Medical Systems	HEX	Class II	2010-12-20
K103538	Hardydisk Ast Ceftaroline, 30 Ug Model Z939	Hardy Diagnostics	JTN	Class II	2010-12-17
K103432	Unity Network Id	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2010-12-17
K103392	Chad Therapeutic Evolution Electronic Oxygen Conserver	Inovo, Inc.	NFB	Class II	2010-12-17
K103360	Dimension Vista Digitoxin Calibrator - Dgtx Cal	Siemens Corp.	JIT	Class II	2010-12-17
K102715	Regional Oximeter	Nonin Medical, Inc	MUD	Class II	2010-12-17
K102709	Peak Plasmablade Plus Tissue Dissection Device	Peak Surgical, Inc.	GEI	Class II	2010-12-17
K102106	Nihon Khden Prefense Edns-9000 Series Central Nurse Station	Nihon Kohden Corp.	DRG	Class II	2010-12-17
K101563	Smarto	Jeil Medical Corporation	KIJ	Class I	2010-12-17
K100576	High Pressure Sets-400 Psi	Abbott Medical	FPA	Class II	2010-12-17
K103536	Ibed Wireless with Ibed Awareness	Stryker Corp.	FNL	Class II	2010-12-16
K103408	Posterior Lateral Plates	Depuy Orthopaedics Inc.	HRS	Class II	2010-12-16
K103249	Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim	Medtronic, Inc.	LZA	Class I	2010-12-16
K103147	Novel III Spinal Fixation and Adjustable Bridge System	Medyssey Co., Ltd.	MNI	Class II	2010-12-16
K102766	Composix L/p Mesh with Echo Ps Positioning System	C.R. Bard Inc	FTL	Class II	2010-12-16
K102755	Ceralas E/ 1470Nm Fiber-Coupled Diode Laser Family; Crealas Hpd Multiwavelenght 980Nm/ 1470Nm Fiber-Coupled Diode Laser	Biolitec, Inc.	GEX	Class II	2010-12-16
K102624	Avita Wrist Type Blood Pressure Monitor	Avita Corporation	DXN	Class II	2010-12-16
K102419	Gsp Neonatal Irt Kit (3306-001U)	Wallac Oy, Subsidiary of Perkinelmer	JNO	Class I	2010-12-16
K102341	Vipi Block	Vipi Industria,Comercio,Exportacao E Importacao de	EBG	Class II	2010-12-16
K102323	Cervical Standalone Intervertebral Body Fusion Device	Theken Companies LLC	OVE	Class II	2010-12-16
K102249	Expedium Spine System	Depuy Spine, A Johnson & Johnson Company	NKB	Class II	2010-12-16
K102214	Endo Flip	Crospon, Ltd.	FFX	Class II	2010-12-16
K102084	Stimpod Nms450 Nerve Stimulator	Xavant Technology (Pty) Ltd	BXN	Class II	2010-12-16
K102029	Peak Pulsar II Generator Model Ps100-102	Peak Surgical, Inc.	GEI	Class II	2010-12-16
K101956	Straumann Membragel	Straumann USA (on Behalf of Institut Straumann AG)	NPK	Class II	2010-12-16
K101659	Supercross Microcatheter (130 Cm), Supercross Microcatheter (150 Cm) Model 5300, 5301	Vascular Solutions LLC	DQY	Class II	2010-12-16
K101558	Gnr Traffic Light Pna Fish	Advandx, Inc.	JSS	Class I	2010-12-16