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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2953 of 3529

510(k) clearances, page 2953 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854009	Abuscreen Radioimmunoassay for Amphetamine-High Sp	Roche Diagnostic Systems, Inc.	DJP	Class II	1985-10-15
K853978	Tdx Amylase	Abbott Medical	CIX	Class II	1985-10-15
K853921	All Kinds of Sunglasses	Winsburn Company, Ltd.	HQY	Class I	1985-10-15
K853888	Amresco Flow Pac Creatinine Color Reagent 2310 &	American Research Products Co.	CGX	Class II	1985-10-15
K853866	Pantex Direct Estradiol Coated Tube Radioimmunoass	Pantex, Div. Bio-Analysis, Inc.	CHP	Class I	1985-10-15
K853865	Pantex Direct Testosterone Coated Tube Radioimmuno	Pantex, Div. Bio-Analysis, Inc.	CDZ	Class I	1985-10-15
K853858	Il Test Theophylline Assay	Allied Instrumentation Laboratory	KLS	Class II	1985-10-15
K853855	Xtal X-150 Operating Microscope	Xtal Corp.	HRM	Class I	1985-10-15
K853847	Super Micro Blades	Kdans Surgical, Inc.			1985-10-15
K853834	Vision Theophylline	Abbott Medical	KLS	Class II	1985-10-15
K853803	Fetal Bovine/fetal Calf Serum, Newborn, Horse, Rab	Z.L. Bocknek Laboratories, Inc.	KIS	Class I	1985-10-15
K853723	Zeiss Operating Keratometer	Carl Zeiss, Inc.	HLQ	Class I	1985-10-15
K853668	Orc Oracle	Optical Radiation Corp.	HLQ	Class I	1985-10-15
K853457	Coburn I/a System	Coburn Optical Ind., Inc.	HQE	Class II	1985-10-15
K852936	The Fieldmaster Model 275	Synemed, Inc.	HPT	Class I	1985-10-15
K852804	Medcyc Superconduct Isocen Neutron Therapy Sys	Medcyc. Corp.	IWL	Class II	1985-10-15
K853818	Medtronic Model 6405	Medtronic, Inc.	LDF	Class II	1985-10-11
K853564	Lifepak 200	Physio Control, Inc.	MKJ	Class III	1985-10-11
K853439	Model 43130A Defibrillator	Hewlett-Packard Co.	LDD	Class II	1985-10-11
K853410	Model 492-03 Polyflex Implantable Pacing Lead	Intermedics, Inc.	DTR	Class II	1985-10-11
K853354	Medic 4	Kone Instruments, Inc.	LDD	Class II	1985-10-11
K853262	Cardio Data Pacerecorder Pr3	Cardio Data	DSH	Class II	1985-10-11
K853213	Fukuda Denshi Model/ds-1030A Dynascope Series Mon	Fukuda Denshi USA, Inc.	DSI	Class II	1985-10-11
K853126	Bio Pack Model 200	Bio Medicus, Inc.	DWA	Class II	1985-10-11
K853080	William Harvey Hybid Oxygenator H-1700	C.R. Bard Inc	DTZ	Class II	1985-10-11
K852984	Shiley Csd Extension Line with Filter	Shiley, Inc.	DWF	Class II	1985-10-11
K852958	Pacepac	Medical Data Electronics	DRO	Class II	1985-10-11
K852872	Angiomedics Softip Catheter	Angiomedics, Inc.	DQO	Class II	1985-10-11
K852238	Ipg-300	Thornton Associates, Inc.	DSB	Class II	1985-10-11
K853938	Lx 300 Tissue Processor	Innovative Medical Systems, Inc.	IEO	Class I	1985-10-10
K853897	Citrex H	Bio/Data Corp.	GGW	Class II	1985-10-10
K853665	Splash Adaptor	Ohio Medical Research, Inc.	BYH	Class I	1985-10-10
K853622	Sure Count 30 Count Foam & Magnetic 92-3030	Kleen Test Products Corporation			1985-10-10
K853472	Finger Tourniquette	Joseph B. Marogil	GAX	Class I	1985-10-10
K853429	Coulter Counter Model M5	Coulter Electronics, Inc.	GKL	Class II	1985-10-10
K853291	Gp-100 Adult Electrosurgical Ground Pad/200 & 300	ZOLL Medical Corporation	HAM	Class II	1985-10-10
K853210	Mst-1050-II X-Ray Unit	Radiological Engineering, Inc.	KPA	Class I	1985-10-10
K853175	Rei-90/15	Radiological Engineering, Inc.	IXR	Class II	1985-10-10
K853040	Pressure Gauge	Erie Medical	BXH	Class I	1985-10-10
K852992	Para Check (Aka Eight Check-C)	Streck Laboratories, Inc.	JPK	Class II	1985-10-10
K852942	World Portable Cautery	Sturgeon Engineering Co.	GEI	Class II	1985-10-10
K852935	Eschmann Electrosurgical Unit, Model Td411	Eschmann Bros. & Walsh, Ltd.	GEI	Class II	1985-10-10
K852920	Quadra Cath Elect(3mm Sizes) 1990J, Jf, Jp + Jpf	Neuromed, Inc.	GZB	Class II	1985-10-10
K852865	Optical Disc Unit	General Electric Co.	JAK	Class II	1985-10-10
K852848	Fdp Assay-20 Test Kit	American Bioproducts Co.	GHH	Class II	1985-10-10
K852772	Gas Evacuation Accessory	Siemens Elema AB	CBN	Class II	1985-10-10
K852771	Pc Interface	Siemens Elema AB	CBK	Class II	1985-10-10
K851635	Diagnon Herpes Immunoperoxidase Typing Test	Diagnon Corp.	GQL	Class II	1985-10-10
K852282	Schiller Miniscope Ms-2 EKG Scope	Armstrong Ind., Inc.	DPS	Class II	1985-10-09
K852281	Schiller EKG Combi Msg-Im Scope & Recorder	Armstrong Ind., Inc.	DPS	Class II	1985-10-09