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 3094 of 3528

510(k) clearances, page 3094 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840364	Registrex 1000 Plus Digital Radiography	Advanced Technology Laboratories, Inc.	JAA	Class II	1984-03-19
K840355	Deseret Multilumen Subclavian Jugular	Parke-Davis Co.	FOZ	Class II	1984-03-19
K840236	Emit St Serum Benzodiazepine Assay	Syva Co.	JXM	Class II	1984-03-19
K840229	Control Cover Gown	Kimberly-Clark Corporation	FYC	Class II	1984-03-19
K840216	Sodium/potassium Reagent Sys	Sclavo, Inc.	JGT	Class II	1984-03-19
K840215	Phosphorus Reagent System	Sclavo, Inc.	CEO	Class I	1984-03-19
K840214	Calcium Reagent Sys	Sclavo, Inc.	CHZ	Class II	1984-03-19
K840213	Blood Urea Nitrogen Reagent Sys	Sclavo, Inc.	JGZ	Class II	1984-03-19
K840194	Emit St Serum Barbiturate Assay	Syva Co.	DIS	Class II	1984-03-19
K840183	Deseret Multilumen Subclavian Jugular	Parke-Davis Co.	FOZ	Class II	1984-03-19
K840174	Lh Quik Ria Kit	Pacific Biotech, Inc.	CEP	Class I	1984-03-19
K840171	Emit St Urine Ethyl Alcohol Assay	Syva Co.	DML	Class II	1984-03-19
K840127	Curietron	Syncor Intl. Corp.	JAQ	Class II	1984-03-19
K840111	Total Bilirubin	Fisher Scientific Company L.L.C.	CIG	Class II	1984-03-19
K840061	Emit St Urine Phencyclidine Assay	Syva Co.	LCM	Unclassified	1984-03-19
K840060	Emit St Urine Methadone Assay	Syva Co.	DJR	Class II	1984-03-19
K840050	Sopheia T3 Eia Kit	Siemens Healthcare Diagnostics Inc.	CDP	Class II	1984-03-19
K834590	Accuflex	Micromedic Systems	JQW	Class I	1984-03-19
K834588	Oxymizer-Pendant	Chad Therapeutics, Inc.	NFB	Class II	1984-03-19
K834550	Emit St Serum Tricyclic Antidepressant	Syva Co.	LFG	Class II	1984-03-19
K834549	Emit St. Urine Cocaine Metabolite	Syva Co.	DIO	Class II	1984-03-19
K834477	Dispos. Scott Cannulas 16-1054 Etc.	Cerenovus, Inc.	HCA	Class II	1984-03-19
K834407	Sterile Disposable Spinal Needles	Hydro-Med Products, Inc.	FMI	Class II	1984-03-19
K834354	Ophtec Rust Ring Remover	JEDMED Instrument Company	HOG	Class I	1984-03-19
K834353	Ok Flash Sterilization Indicator	Propper Mfg Co Inc	JOJ	Class II	1984-03-19
K834350	Acufex Drez Communicating Drill Guide	Acufex Microsurgical, Inc.	FZX	Class I	1984-03-19
K834227	Deseret Subclavian Jugular Cath. Set	Parke-Davis Co.	FOZ	Class II	1984-03-19
K834152	Ethylene Oxide Detector Gld-1-07	Calnor of el Paseo, Inc.	FLE	Class II	1984-03-19
K834074	Percutaneous Sheath Introducer Tray	Packaging Technologies, Inc.	DYB	Class II	1984-03-19
K833990	Spinal Cord Stimulation Sys Se-4	Medtronic, Inc.	GZB	Class II	1984-03-19
K833977	Seralyzer Drug Assay Control Serum	Miles Laboratories, Inc.	DLJ	Class II	1984-03-19
K833954	Melolite	Smith & Nephew, Inc.	KGX	Class I	1984-03-19
K833851	Hcg Ria	Syncor Intl. Corp.	JHI	Class II	1984-03-19
K833814	Sani Catch Ba	Concord Laboratories, Inc.	LIO	Class I	1984-03-19
K833676	Surgical Vessel Dilators-Catheriza-	Cimed Intl., Inc.	DWP	Class II	1984-03-19
K833599	Modified Hps Hip Prosthesis	Depuy, Inc.	KWL	Class II	1984-03-19
K833442	Pediatric Right Atrial Catheter 1/3Mm	Quinton, Inc.	LJS	Class II	1984-03-19
K833351	Demand Oxygen Controller	Healthdyne, Inc.	BZB	Class I	1984-03-19
K832825	Seralyzer Theophylline Reagent Strips	Miles Laboratories, Inc.	KLS	Class II	1984-03-19
K831586	Cm-VII Physiologic Analyzer	Cybermedic, Inc.	BZM	Class II	1984-03-19
K840960	Pall Coalescer	Pall Biomedical Products Co.	CAH	Class II	1984-03-16
K840897	Oxygen Tubing	Medical Technologies of Georgia	CAT	Class I	1984-03-16
K840844	Endo-Secure	Exidyne, Inc.	JAY	Class I	1984-03-16
K840698	Powermat Vrp-1 X-Ray Imaging	Powers Chemco, Inc.	IWZ	Class I	1984-03-16
K840678	Uxm Model 8188	Universal X-Ray	IZX	Class II	1984-03-16
K840660	Posterior Capsulotomy Cystitome	Sharpoint, Inc.	HNY	Class I	1984-03-16
K840659	Anterior Capsulectomy Cystitome	Sharpoint, Inc.	HNY	Class I	1984-03-16
K840638	Portable Transit Chair	Poirier S.A.	INM	Class I	1984-03-16
K840471	Eye Spear	Surgicot, Inc.	HOZ	Class II	1984-03-16
K840444	Neonate Mask for Babies	Richards Medical Co., Inc.	HOY	Class I	1984-03-16