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 1534 of 3531

510(k) clearances, page 1534 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020902	Serralester	Serral, S.A. de C.V.	GAT	Class II	2002-05-20
K020867	Bone Marrow Aspiration Needle, Model Bmb1110j, Bone Marrow Harvest Needle, Model Bmhn1104vx, & Bone Marrow Biopsy Needl	Worldwide Medical Technologies, LLC	KNW	Class II	2002-05-20
K020849	Apex 800 Laser System, Model Apex 800	Iridex Corporation	GEX	Class II	2002-05-20
K020780	Transtar Intracranial Pressure Transducer, Model Mx950icp	Medex, Inc.	GWM	Class II	2002-05-20
K020602	Synthes Pilon Plate	Synthes GmbH	HRS	Class II	2002-05-20
K020574	Tissuelink Bipolar Floating Ball Device	Medtronic Navigation, Inc	GEI	Class II	2002-05-20
K020541	Agility Ankle Revision Prosthesis	Depuy, Inc.	HSN	Class II	2002-05-20
K020298	Galileo Cas/nav Tkr System	Plus Orthopedics	HAW	Class II	2002-05-20
K021487	Simplicity Easy Access P Infusion Set	Sterling Medivations, Inc.	FPA	Class II	2002-05-17
K021274	Pain-Mate Pain Management System with Dual Port 1+1, 2+2, Models 2C1718, 2C1719	Baxter Healthcare Corporation	MEB	Class II	2002-05-17
K021256	Z3 Guide Catheter	Medtronic, Inc.	DQY	Class II	2002-05-17
K021219	Smartwire/smartmap Pressure System	Jomed, Inc.	DQX	Class II	2002-05-17
K021212	24Cm Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips	Spire Biomedical, Inc.	MSD	Class II	2002-05-17
K021095	Holy Dragon Brand Acupuncture Needles	Wujiang City Hua Xin Medical Appliance Co., Ltd.	MQX	Class II	2002-05-17
K020939	Microscan Microstrep Plus Panel-Tetracycline	Dade Microscan, Inc.	LTT	Class II	2002-05-17
K020801	Quickvue One-Step Hcg-Combo	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	2002-05-17
K020799	Quickvue One-Step Hcg-Urine	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	2002-05-17
K020747	Amsco Century Medium Sterilizer 26 X 26	STERIS Corporation	FLE	Class II	2002-05-17
K020113	Vector F Series High-Speed Dental Handpieces	Vector Research & Development	EBF	Class II	2002-05-17
K012496	Carbon Post	J. Morita USA, Inc.	ELR	Class I	2002-05-17
K011344	Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400	Collins Medical, Inc.	BZC	Class II	2002-05-17
K021514	Philips Pls9w/12/2p Uvb	Philips Lighting Co.	FTC	Class II	2002-05-16
K021396	Dermagrip and Multiple Powder Free Purple Nitrile Examination Gloves, Non-Sterile	Wrp Specialty Products Sdn. Bhd.	LZA	Class I	2002-05-16
K021382	Synthes (USA) Automated Tack Driver	Synthes (USA) Products LLC	JEY	Class II	2002-05-16
K021371	Sunspex Technologies Model Se 02	Sunpex Technology Co., Ltd.	INI	Class II	2002-05-16
K021367	Sterngold 66, Model #1180230	Sterngold	EJS	Class II	2002-05-16
K021242	Portalloy 54	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-05-16
K021232	Constellation Catheters, Model 8031M	Boston Scientific Corporation	MTD	Class II	2002-05-16
K021192	Qaca Igg/igm Elisa Kit Hrp	Cheshire Diagnostics, Ltd.	MID	Class II	2002-05-16
K021145	Accommodator Wheelchair, Model #2000X	Marken International, Inc.	IOR	Class I	2002-05-16
K021092	Philips Tl 20W/01rs UV-B, Philips Pl-S 9W/01/2p UV, and Philips Pl-L 36W/01/4p UV-B	Philips Lighting Co.	FTC	Class II	2002-05-16
K021031	Ebi Xfix Rail System	Ebi, LLC	KTT	Class II	2002-05-16
K021024	Hemosil High Abnormal Control Assayed	Instrumentation Laboratory Co.	GGN	Class II	2002-05-16
K021001	Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves	Shanghai Glovmax Enterprise Co.,Ltd	LZA	Class I	2002-05-16
K020956	Vivosonic Dianostic Ultrasound Imaging Coupling Media	Microtek Medical LLC	MUI	Class II	2002-05-16
K020927	Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	2002-05-16
K020887	Ebi Ais Spine System	Ebi, LLC	MQP	Class II	2002-05-16
K020847	Xtrac Excimer Laser System, Model Al7000	Photo Medex, Inc.	GEX	Class II	2002-05-16
K020734	Surge-Free Aspiration Adapter	Staar Surgical AG	HQC	Class II	2002-05-16
K020608	Hd/hdt, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens)	Poly Vue Technolgies, Inc.	LPL	Class II	2002-05-16
K020591	Bclear	Lumenis Ltd	FTC	Class II	2002-05-16
K020562	Apex Intramedullary Nail System	Magly Orthopedics, LLC	HSB	Class II	2002-05-16
K020516	Care Ifc Plus	Care Rehab, Inc.	LIH	Class II	2002-05-16
K020514	Pulpdent Glaze II	Pulpdent Corporation	KLE	Class II	2002-05-16
K020513	Epy-50	DDC Technologies, Inc.	GEX	Class II	2002-05-16
K020512	Mti St#1 Silicone Pessary	Medical Technology and Innovations, Inc.	HHW	Class II	2002-05-16
K020398	Microscan Synergies Plus Gram Negative Mic/combo Panels with Ampicillin (0.25-128 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2002-05-16
K014235	Osseotite Nt Dental Implants & Accessories	ZimVie US Corp LLC	DZE	Class II	2002-05-16
K013966	Apatight-Tcp Bone Graft Substitute	Cerabio, LLC	MQV	Class II	2002-05-16
K013764	Immix Bone Graft Extender	Osteogenics Biomedical, Inc.	KKY	Class II	2002-05-16