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 1958 of 3531

510(k) clearances, page 1958 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962646	Prime Modular Endo Head	Orthopaedic Innovations, Inc.	KWL	Class II	1996-09-23
K962592	Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems	Alcon Laboratories	GEX	Class II	1996-09-23
K962462	Musclemax Plus Electrical Muscle Stimulator	Smith and Nephew Donjoy, Inc.	IPF	Class II	1996-09-23
K962043	Auto Suture Modified Vcs Clip Applier	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1996-09-23
K961826	Digipan	Trophy Radiologie	EHD	Class II	1996-09-23
K961522	Kirschner Wire (K-Wire) and Steinmann Pin	Synvasive Technology, Inc.	HTY	Class II	1996-09-23
K961356	Mammary Sizer	General Surgical Innovations	MRD	Unclassified	1996-09-23
K954728	Prod No. 01-1694 - 4X4 Foam Dressing	Continental Medical Laboratories, Inc.	KMF	Class I	1996-09-23
K953823	Arterial Venous Blood Tubing Set	Medisystems Corp.	FJK	Class II	1996-09-23
K963607	Horizon 1 and 2 Programable Full Shell and in the Canal	Midwest City Hearing Aid Center	ESD	Class I	1996-09-20
K963252	Tban	Boston Scientific Corporation	EOQ	Class II	1996-09-20
K963044	Endobeam	Corin USA	GCT	Class II	1996-09-20
K963043	Endospot	Corin USA	FCW	Class II	1996-09-20
K963006	Scion Saphenous Vein Harvesting System	Scion International, Inc.	GAD	Class I	1996-09-20
K962986	Maxxus Powder Free Orthopaedic Latex Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1996-09-20
K962896	Kodak Digital Science Remote Cassette	Eastman Kodak Company	KPR	Class II	1996-09-20
K962806	Ohmeda-Ohio Cae Plus Incubator	GE Healthcare	FMZ	Class II	1996-09-20
K962677	Esteem 1.5T MRI System	Elscint Mr, Inc.	LNH	Class II	1996-09-20
K962590	Signaldress	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1996-09-20
K962589	Aurora Diagnostic Workstation	Aurora Technology Pte. Ltd.	LLZ	Class II	1996-09-20
K962544	Micro Diamond-Point Dissection Needles	Dsp Worldwide	JOS	Class II	1996-09-20
K962503	Guglielmi Detachable Coil	Target Therapeutics	HCG	Class II	1996-09-20
K962494	Perioglas - Bioglass Bone Graft Particulate	Usbiomaterials Corp.	LYC	Class II	1996-09-20
K962465	Til313 Abutment and Retaining Screw Systems	ZimVie US Corp LLC	DZE	Class II	1996-09-20
K962427	Cobe Centrysystem 700 Hg Hemodialyzer	Gambro Healthcare	KDI	Class II	1996-09-20
K962236	Scarf Thread-Head Screw	Landos, Inc.	HWC	Class II	1996-09-20
K961580	Port-a-Cath P.a.s. Port II Implantable Venous Access Sytems	Sims Deltec, Inc.	LJT	Class II	1996-09-20
K961140	Fluoroplus Cardiac Tv	CMT Medical Technologies, Ltd.	JAA	Class II	1996-09-20
K960865	Step Option to Prism 2000	Philips North America LLC	KPS	Class II	1996-09-20
K960087	Soribie Resurfacing Total Elbow System (Proposed Name)	Wrightmedicaltechnologyinc	JDB	Class II	1996-09-20
K960078	Asthma Monitor	Erich Jaeger, Inc.	BZG	Class II	1996-09-20
K960024	Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle Wrench	Storz Instrument Co.	HQC	Class II	1996-09-20
K955577	Eclipse Version 3.0	Stellate Systems	OLT	Class II	1996-09-20
K955548	Chips Powered Wheelchair	International Healthcare Solutions, Inc.	ITI	Class II	1996-09-20
K955547	Chips Standup Wheelchair	International Healthcare Solutions, Inc.	ITI	Class II	1996-09-20
K953943	Axsym Cmv Igg Antibody Assay	Abbott Medical	LFZ	Class II	1996-09-20
K963197	On.site Alcohol	Ansys, Inc.	DML	Class II	1996-09-19
K962692	Zomed Model 30-6 Multielectrode Array Probe	Zomed Intl.	GEI	Class II	1996-09-19
K962560	Vitality Hip Stem	Encore Orthopedics, Inc.	JDI	Class II	1996-09-19
K962525	Ultra-Safe Ultrasonic Aspirator System	Morwel Corp.	LFL	Unclassified	1996-09-19
K962448	Primaloc Cemented Hip System	Ortho Development Corp.	KWY	Class II	1996-09-19
K962402	Amo Prestige Day Pack (Allergan, Inc.)	Allergan	HQC	Class II	1996-09-19
K962216	Tsh (Microwell) Elisa	Biomerica	JLW	Class II	1996-09-19
K961716	Vaso-Safe Arterial Embolectomy Cathete	Ideas for Medicine, Inc.	DXE	Class II	1996-09-19
K960674	Contrast Injection Lines	B.Braun Medical, Inc.	DXT	Class II	1996-09-19
K963157	Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify)	Oratec Interventions, Inc.	GEI	Class II	1996-09-18
K962843	Multitrans Culture Collection and Transport System	Starplex Scientific Corp.	JSM	Class I	1996-09-18
K962441	Prospore(stearo for Steam Sterilizer)	Raven Biological Laboratories, Inc.	FRC	Class II	1996-09-18
K962429	Safety Vest	Johnson & Johnson Professionals, Inc.	FMQ	Class I	1996-09-18
K962151	Ryder Lacrimal Intubationset	Ryder Intl. Corp.	OKS	Unclassified	1996-09-18