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 2915 of 3529

510(k) clearances, page 2915 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860904	Video Printer, Model 3200	MEDLINE INDUSTRIES, LP - Northfield	KQM	Class I	1986-03-28
K860859	Uva Sun Systems	Bremi	FTC	Class II	1986-03-28
K860856	Silgmann Solarium Sun-Mobil Model 0918	Solarium Tanning Hut	FTC	Class II	1986-03-28
K860852	Sapphire Blade Surgical Knife	Med-Tech Develoment Corp.	HNN	Class I	1986-03-28
K860851	Allegro Ige Enzyme Immunoassay System	Nichols Institute Diagnostics	DGO	Class II	1986-03-28
K860763	Radtech Vascular Stent	Radtech, Inc.			1986-03-28
K860756	Grosse and Kempf Locking Nail System, Non-Slot Rod	Howmedica Corp.	HSB	Class II	1986-03-28
K860739	Chick Surigical Light	Professional Medical Products, Inc.	FSY	Class II	1986-03-28
K860650	90 Degree Elbow & Straight Connector	Intertech/Ohio	BZA	Class I	1986-03-28
K860644	Ss-A/ss-B Autoantibody Test System	IMMUNO CONCEPTS, NA, Ltd.	LLL	Class II	1986-03-28
K860629	Biogram Apo A1/b	Bio-Rad	MSJ	Class I	1986-03-28
K860491	Osteo-Mesh Cranial Fairing	Xomed, Inc.			1986-03-28
K860370	Safe Sun 700 Home Tanning Unit	Safe Sun Corporation of America, Inc.	FTC	Class II	1986-03-28
K860256	Brawn and Groshong Catheters	Catheter Technology Corp.	FOZ	Class II	1986-03-28
K860138	No. 615 Determination of Ceruloplasmin in Serum	Sigma Diagnostics, Inc.	DDB	Class II	1986-03-28
K860137	Enzymun-Test Ferritin	Boehringer Mannheim Corp.	DBF	Class II	1986-03-28
K860107	Sys*stim 206 (Model-Me 206)	Mettler Electronics Corp	IPF	Class II	1986-03-28
K855249	Midification Sys*stim 207 (Model-Me207)	Mettler Electronics Corp	IPF	Class II	1986-03-28
K854386	Model 20 Previously Hand-Held CO2 Laser System	Directed Energy, Inc.	GEX	Class II	1986-03-28
K853541	Sp 4	Robert Bosch Corp.			1986-03-28
K853154	Hv-4	Robert Bosch Corp.	IPF	Class II	1986-03-28
K861056	Straight Adapt W/temp Sensing Port/closure Plug	Intertech/Ohio	BZA	Class I	1986-03-27
K860927	Hd Crystaline Suction Tip	Hospital Disposables, Inc.	JOL	Class II	1986-03-27
K860837	Hoyer One-Touch Power Lifter	Ted Hoyer & Co., Inc.	FSA	Class I	1986-03-27
K860800	Rosenthal-French Nebulization Dosimeter	Laboratory for Applied Immunology, Inc.	CCQ	Class I	1986-03-27
K860714	Ace Aim - Cpm Hand Unit	Buckman Co., Inc.	JFA	Class I	1986-03-27
K860693	Pulmanex (Tm)	Life Design Systems, Inc.	BTM	Class II	1986-03-27
K860226	Force Evaluation and Testing System (Fets)	Hoggan Health Industries, Inc.	LBB	Class II	1986-03-27
K860128	Modac-Xxxx Intensive Monitoring of EEG	Grass-Telefactor Product Group	GYE	Class II	1986-03-27
K860082	Thermotron 918	Medical Microwave Research Corp.	IOA	Class II	1986-03-27
K854927	Icor Calaric Measurement Unit (Cmu)	Icor AB	BZL	Class II	1986-03-27
K854801	Ms-189 Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1986-03-27
K854268	Del Mar Avionics 5509A Physioscanner EEG Scanner	Del Mar Avionics	GWQ	Class II	1986-03-27
K854266	Sterile Laser Resistant Surgical Field Drape	Lasersafe, Inc.			1986-03-27
K854249	Computer Assisted Diabetic Intruction	Applied Biomedical Computations, Inc.	NDC	Class II	1986-03-27
K860964	White Silver Solder and Yellow Silver Solder	Austenal Dental, Inc.	EJS	Class II	1986-03-26
K860963	'E-Z Floss' and 'Lazy Floss'	Login Industries, Ltd.	JES	Class I	1986-03-26
K860911	Austenal Hyco Alginate Impression Material	Austenal Dental, Inc.	ELW	Class II	1986-03-26
K860769	Dental Floss Holder	Sewon Industry	JES	Class I	1986-03-26
K860737	Teen Clean, Retainer Cleaner	Teen Care, Inc.	EFT	Class I	1986-03-26
K860627	Sci-Pharm Unifil Anterior/posterior Liquid/paste	Scientific Pharmaceuticals, Inc.	EBF	Class II	1986-03-26
K860608	Artificial Teeth, Porcelain, Modified	Dentsply Intl.	ELL	Class II	1986-03-26
K860569	Endodontic Root Canal Plugger	Dentsply Intl.	EKR	Class I	1986-03-26
K860494	7.5 Mhz Short Focus Fluid Offset Probe #041-726T	Ausonics Pty, Ltd.	ITX	Class II	1986-03-26
K860486	Actisorb Activated Charcoal Dressing	Johnson & Johnson Professionals, Inc.	FRO	Unclassified	1986-03-26
K860324	Dental Floss Card	Washburn Laboratories	JES	Class I	1986-03-26
K855183	Cofield Shoulder System	Richards Medical Co., Inc.	KWS	Class II	1986-03-26
K855125	Physiological Telemetry Patient Monitoring System	Honeywell, Inc.	DRT	Class II	1986-03-26
K854828	Sci-Pro, Prophylaxis Paste	Scientific Pharmaceuticals, Inc.	EJR	Class I	1986-03-26
K854696	Op II Visible Light Curing System	Almore Intl., Inc.	EBZ	Class II	1986-03-26