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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3197 of 3528

510(k) clearances, page 3197 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822934	Syva Advance Emit AED Valproic Acid Cont	Syva Co.	LAS	Class I	1982-10-27
K822933	Syva Advance Emit AED Valproic Acid Assa	Syva Co.	LEG	Class II	1982-10-27
K822886	Gonorrhea Transette 3	Spectrum Diagnostic, Inc.	JSM	Class I	1982-10-27
K822884	Uric Acid 75Cdo	Technicon Instruments Corp.	CDO	Class I	1982-10-27
K822860	Ria Ssist Ti-59 Magnetic Card Programs	Ventrex Laboratories, Inc.	JQP	Class I	1982-10-27
K822852	Triglyceride Calibrator	Harleco Diagnostics	JIT	Class II	1982-10-27
K822850	Moni-Tro Es Chemistry Control Level IX	American Dade	JJY	Class I	1982-10-27
K822845	Sopheia Cortisol Eia Kit	Siemens Healthcare Diagnostics Inc.	CGR	Class II	1982-10-27
K822840	Radioimmunoassay, Human Chorrionic	Bioclinical Group	JHI	Class II	1982-10-27
K822827	Hish Eia Diagnostic Kit	Abbott Medical	JLW	Class II	1982-10-27
K822811	Containers of Sterile Water Os Saline	American Pharmaseal Div. Ahsc	BTO	Class II	1982-10-27
K822800	Picolite	United Technologies Packard	JJQ	Class I	1982-10-27
K822772	Microfluor Reader	Dynatech Corp.	KHO	Class I	1982-10-27
K822605	Toxoplasma Gondii Antibody Igg	Immulok, Inc.	LJK	Class II	1982-10-27
K822449	Tpk 1980/1	Plantex USA, Inc.	LCX	Class II	1982-10-27
K822017	Tympanostomy Tubes & Various Types	Kelleher Corp.	ETD	Class II	1982-10-27
K820610	Gelrite	Kelco	JSK	Class I	1982-10-27
K822993	Senatek	American Health Tech., Inc.	HST	Class I	1982-10-26
K822957	Purcast	J. Aderer, Inc.	EJH	Class II	1982-10-26
K822956	G Cast	J. Aderer, Inc.	EJT	Class II	1982-10-26
K822951	Spherex E.c.t.	Jeneric Ind.	EJJ	Class II	1982-10-26
K822947	Neptune	Jeneric Ind.	EJH	Class II	1982-10-26
K822941	Netilmicin Fluorescent Immunoassay	American Diagnostic Corp.	LCE	Class II	1982-10-26
K822931	Scr Wrap	Fox Converting, Inc.	FRG	Class II	1982-10-26
K822928	Disposable Micro-Infusion System	Orange Medical Instruments, Inc.	FMF	Class II	1982-10-26
K822844	Pentax Bronchofiberscope #Fb-19E	Pentax Precision Instrument Corp.	EOQ	Class II	1982-10-26
K822578	Micromedic Estriol Ria Kit	Micromedic Systems	CGI	Class I	1982-10-26
K822257	Various Types of Light Source Handles	Kelleher Corp.	EOQ	Class II	1982-10-26
K822241	Folate/b12 Duo-Bead Radioassay	Abbott Medical	CEN	Class I	1982-10-26
K820945	Sera for Antinuclear Antibodies	Centers for Disease Control and Prevention	DHN	Class II	1982-10-26
K822959	Endoscopic Videosystem	Eder Instrument Co, Inc.	FET	Class II	1982-10-22
K822950	Rx Universal	Jeneric Ind.	EJS	Class II	1982-10-22
K822949	Rx Sfc	Jeneric Ind.	EJT	Class II	1982-10-22
K822948	Rx Biocast	Jeneric Ind.	EJH	Class II	1982-10-22
K822911	Anazyme Ana Peroxidase Test System	Clinical Sciences, Inc.	DAA	Class II	1982-10-22
K822896	Cavidry	Parker Laboratories, Inc.	EJH	Class II	1982-10-22
K822893	G.e.v. Disposable Scalpels	Ascep, Inc.	GDX	Class I	1982-10-22
K822889	Model #6200 Oxygen Concentrator	Hudson Oxygen Therapy Sales Co.	CAW	Class II	1982-10-22
K822871	Model Bx-3000 Oxygen Concentrator	Healthdyne, Inc.	CAW	Class II	1982-10-22
K822846	Pentax Fc-38La & Fc-38Sa Colonofiber	Pentax Precision Instrument Corp.	FDF	Class II	1982-10-22
K822816	Dual Servo Heated Respiratory Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1982-10-22
K822815	Model 700 Gastroreflux Monitor/amalyzer	Del Mar Avionics	FFT	Class I	1982-10-22
K822794	Respironics Endo Tube Control Sys	Respironics, Inc.	CBH	Class I	1982-10-22
K822793	Pio Root Canal Indicator	National Patent Development Corp.	EIL	Class I	1982-10-22
K822790	Micro-Craft Oscillating Saw Handpiece	Xomed, Inc.	KIJ	Class I	1982-10-22
K822764	Lung Diffusion Mixture	Liquid Carbonic Corp.	BXK	Class I	1982-10-22
K822763	Clinical Gas Mixture-Non-Flammable	Liquid Carbonic Corp.	BXK	Class I	1982-10-22
K822762	Clinical Gas Mixture-Flammable	Liquid Carbonic Corp.	BXK	Class I	1982-10-22
K822753	Blood Gas Mixture	Liquid Carbonic Corp.	BXK	Class I	1982-10-22
K822752	Anaerobic Carbon Dioxide	Liquid Carbonic Corp.	BXK	Class I	1982-10-22