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 2026-10-21, 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 2989 of 3529

510(k) clearances, page 2989 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K845050	Up800 a Universal Printer	Madsen Electronics (Canada), Ltd.	EWO	Class II	1985-05-29
K843010	Bp-800	Pollenex Associated Mills, Inc.	DXN	Class II	1985-05-29
K851811	Slit Camera Model 07-624	Victoreen, Inc.	IXH	Class I	1985-05-28
K851512	Allergenetics Ige Fast Test	Allergenetics	DHB	Class II	1985-05-28
K851462	Bfw Voice Generator	Bfw Laboratories, Inc.	BTO	Class II	1985-05-28
K851213	Zweymuller Cup	Allo Pro Corp.	KWA	Class III	1985-05-28
K851031	Exposcop Mobile Imaging System	Euro-Electronics, Inc.	JAA	Class II	1985-05-28
K850928	V.e.p. Hip -Variable Endo-Prosthesis	Unitas Ent.	KWL	Class II	1985-05-28
K850795	Air Compressor	Bear Medical Systems, Inc.	BTI	Class II	1985-05-28
K850627	Spacelabs-General System Link	Spacelabs, Inc.	DQK	Class II	1985-05-28
K844116	Critikon Cardiac Output Computer W/hemodynamic	Critikon Company, LLC	DXG	Class II	1985-05-28
K843580	Medi-Trace Transduc Phys Pressure Monito	Graphic Controls Corp.	DRS	Class II	1985-05-28
K843055	Accu-Trac	Olympic Medical Corp.	DXN	Class II	1985-05-28
K851984	Lkb-Wallac 1230 Arcus Fluorometer	Lkb Instruments, Inc.	KHO	Class I	1985-05-24
K851945	Varian Aasp Automated Sample Prep. System	Varian Assoc., Inc.	KZR	Class I	1985-05-24
K851930	Tdx Rea Iron/tibc	Abbott Medical	JMO	Class I	1985-05-24
K851923	Amresco Flow Pac Sma Phosphate Buffer Concentrate	Amresco, Inc.	CKA	Class I	1985-05-24
K851287	Radial Immunodiffusion Plates Transferrin	Cooper Biomedical, Inc.	DDG	Class II	1985-05-24
K851282	Radial Immunodiffusion Plates Alpha-2 Macroglobuli	Cooper Biomedical, Inc.	DEB	Class II	1985-05-24
K850858	Ob-Ph - Ph Test Paper	Uro Pharmaceuticals, Inc.	LNW	Class I	1985-05-24
K850704	Rmc Aspirator - Vacuum Pump	Reliance Medical Corp.			1985-05-24
K843206	Cook County Hospital Dressing Change Set	Geneva Laboratories, Inc.	KDD	Class I	1985-05-24
K842094	Xmc-S Tubestand Xmt-S Table Xmh-Ntwall	X-Ray Mfg. & Sales, Inc.	IXQ	Class II	1985-05-24
K851986	Stopcocks	Transamerica Delaval, Inc.	FMG	Class II	1985-05-23
K851920	Compressed Air Connector Disposable Connector	Dhd Medical Products Div. Diemolding Corp.			1985-05-23
K851856	Tracheal/bronchial Differential Ventilation Tube	Sheridan Catheter Corp.	CBI	Class II	1985-05-23
K851798	53-160 to 53-167 Various Biopsy Forceps Yeoman	Artiberia	KNW	Class II	1985-05-23
K851797	53-100 to 53-120 Various Rectal Specula(sims, Math	Artiberia	FFQ	Class I	1985-05-23
K851790	37-200 to 37-246 Various Ophthalmology Scalpels/kn	Artiberia	HNN	Class I	1985-05-23
K851734	Omnimed Superior Transducer Protector	Omni Intl., Inc.	FIB	Class II	1985-05-23
K851658	Capnomed	Draeger, Inc.	CCK	Class II	1985-05-23
K851653	Varian/ximatron 5 Carbon-Fiber Couch Top	Varian Assoc., Inc.	KPQ	Class II	1985-05-23
K851555	Opthalmic Bar Prism	Roseburg SA	HKW	Class I	1985-05-23
K851463	Olbert Catheter Sys for Ureteral Dilation	Meadox Surgimed, Inc.	EZN	Class II	1985-05-23
K851398	Bard Peristomal Paste	C.R. Bard Inc	EXB	Class I	1985-05-23
K851385	Thora-Cath Trocar-Type Chest Drainage Tube	Gesco Intl., Inc.	JOL	Class II	1985-05-23
K851303	Comfort-Ease Electrode	Medtronic, Inc.	GXY	Class II	1985-05-23
K851292	Lovesafe Dotty Condom One Dz. Codoms/box, Dc-20	Manexim Multicorp, Ltd.	HIS	Class II	1985-05-23
K851283	Radial Immunodiffusion Plates-Ceruloplasmin	Cooper Biomedical, Inc.	DDB	Class II	1985-05-23
K851185	Electro-Nerve Stimulator B4/b400	BioMedical Life Systems Inc.	GZJ	Class II	1985-05-23
K851174	Metachrome	Potomac Medical System	LNJ	Class II	1985-05-23
K851147	Autoranging Digital Clinical Thermometer	Micro Idea Instrument Co., Ltd.	FLL	Class II	1985-05-23
K851146	Digital Thermometer	Micro Idea Instrument Co., Ltd.	FLL	Class II	1985-05-23
K851143	Rhinomanometers Nr3, Nr4	And/Or Corp.	BXQ	Class II	1985-05-23
K851029	New Vitajet	Andrew V. Stadler	KZE	Class II	1985-05-23
K851024	Pleur-Evac Autotransfusion System -Tentative	Pfizer Inc	CAC	Class II	1985-05-23
K850978	Olympus Lf-1 Intubation Scope	Olympus Corp.	CAL	Class I	1985-05-23
K850926	Micron One Porta. Ultrasonic Nebulizer	Endotek Development Laboratories	CCQ	Class I	1985-05-23
K850759	Computer Interface - Biofeedback	M.O.E Electronics Research & Prod.	HCC	Class II	1985-05-23
K850751	Dispos. Drainabel Pouch for Ileostomy/colostomy	Biolog, Inc.	EXB	Class I	1985-05-23