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 3160 of 3528

510(k) clearances, page 3160 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831254	Dental Floss Holder	Sewon Industry	JES	Class I	1983-05-09
K831253	Lancer Hemoglobin Analyzer Reagents	Sherwood Medical Co.	KMG	Class II	1983-05-09
K831238	Oxymed	Draeger, Inc.	CCL	Class II	1983-05-09
K831237	Spiromed Respirometer	Draeger, Inc.	BZK	Class II	1983-05-09
K831229	Super Snaps	Shofu Dental Corp.	FHJ	Class II	1983-05-09
K831222	Carbamezepine Reagent Test Kit	Beckman Instruments, Inc.	KLT	Class II	1983-05-09
K831220	Clostridium Difficile Media	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1983-05-09
K831217	Model Bernafon T-86	Bernafon LLC	ESD	Class I	1983-05-09
K831214	Delta Teeth	Dentsply Intl.	ELM	Class II	1983-05-09
K831208	Ige-Quant Diagnostic Test Kit	Leeco Diagnostics, Inc.	DGC	Class II	1983-05-09
K831200	Immunohematological Saline #97139	EMD Millipore Corporation	JCE	Class I	1983-05-09
K831197	Model 343D Hearing Aid	Telex Communications, Inc.	ESD	Class I	1983-05-09
K831195	Westergren Dispette for Esr	Ulster Scientific, Inc.	JPH	Class I	1983-05-09
K831191	Vascular Catheter	Medrad, Inc.	DOY	Class II	1983-05-09
K831190	Vessel Dilator	Medrad, Inc.	DRE	Class II	1983-05-09
K831189	Angiographic Needle	Medrad, Inc.	DQO	Class II	1983-05-09
K831188	Connector Tube	Medrad, Inc.	DOY	Class II	1983-05-09
K831187	Trp	Dms Laboratories	JTO	Class I	1983-05-09
K831186	Rapid Nft	Dms Laboratories	JSN	Class I	1983-05-09
K831184	Cardio Data Pacemaker Recorder	Cardio Data	DSH	Class II	1983-05-09
K831179	Cefazolin 30Mcg. Antimicrobial Suscep	General Diagnostics	JTN	Class II	1983-05-09
K831168	Enteral Delivery Set	Biosearch Medical Products, Inc.	KNT	Class II	1983-05-09
K831167	Enteral Pump Set	Biosearch Medical Products, Inc.	KNT	Class II	1983-05-09
K831162	Energetic Hi-Hum Aersol Unit	Energetic Pulmonary	CAF	Class II	1983-05-09
K831160	Lead Adapters #'S 6016,6022,6017 Etc	Cardiac Pacemakers, Inc.	DTD	Class II	1983-05-09
K831157	Blood Cardioplegia Stainless Steel Cool	American Bentley	DTR	Class II	1983-05-09
K831153	Cefaxolin 30 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1983-05-09
K831124	Biocult - Gc Culture-Paddles	Orion Diagnostica, Inc.	JTY	Class II	1983-05-09
K831119	Luo Currettes #3211	Pmt, Inc.	FZS	Class I	1983-05-09
K831104	Tenzcare Muscle Stimulation Electrodes	3M Company	GXY	Class II	1983-05-09
K831082	Connecting Tubing	The Kendall Company Div. of Tyco Healthcare Group	BYX	Class I	1983-05-09
K831068	Container System	Adler Instrument Company			1983-05-09
K831064	Phase II T3 Radioimmunoassay Kit	Medical & Scientific Designs, Inc.	CDP	Class II	1983-05-09
K831037	Air Burbine Handpiece-Dental Scaling	Taco Dental, Inc.	ELB	Class II	1983-05-09
K831030	Cobas Standards for Glucose & Bun	Roche Diagnostic Systems, Inc.	JIX	Class II	1983-05-09
K831028	Ti-1000 Transport Incubator	Narco Scientific	FPL	Class II	1983-05-09
K831020	Flush Solution Concentrate	Fisher Scientific Company L.L.C.	CHL	Class II	1983-05-09
K831017	Buffer Pack for Abl-1 & Abl-2	Fisher Scientific Company L.L.C.	CHL	Class II	1983-05-09
K831008	Head Strap	Medovations, Inc.	BTK	Class I	1983-05-09
K830983	Airways & Nasopharyngeal Type	Medovations, Inc.	BTQ	Class I	1983-05-09
K830982	Masks	Medovations, Inc.	BSJ	Class I	1983-05-09
K830955	Dental Ceramic for Fabrication of Crown	Dentsply Intl.	EIH	Class II	1983-05-09
K830889	Dexon 'S' Polyglycolic Acid Mesh	Davis & Geck, Inc.	FTM	Class II	1983-05-09
K830884	Surgiteks Percutaneous Antegrade All -	Medical Engineering Corp.	FAD	Class II	1983-05-09
K830857	Harris A.r. C. Acetabular Cup	Howmedica Corp.	JDI	Class II	1983-05-09
K830779	Pressure Function Block for Blood Press	Honeywell, Inc.	DRT	Class II	1983-05-09
K830743	Porous Tip Endocardial Lead	Daig Corp.	DTB	Class III	1983-05-09
K830664	Human Intract Parathyroid Hormone by	Immuno Nuclear Corp.	CEW	Class II	1983-05-09
K830631	Tracheal Tube W/illuminating Locater	Mallinckrodt Critical Care	BTR	Class II	1983-05-09
K830615	Cytomegelisa Stat	M.A. Bioproducts	LFZ	Class II	1983-05-09