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 2026-10-12, 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 3253 of 3528

510(k) clearances, page 3253 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813454	i.v. Filter-Prevent	Pioneer Viggo, Inc.	FPB	Class II	1982-01-05
K813446	IV Filterset 0.22 Micrometer	Imed Corp.	FPB	Class II	1982-01-05
K813445	IV Filterset 5 Micrometer	Imed Corp.	FPB	Class II	1982-01-05
K813422	Scalpel	Abco Dealers, Inc.	GDX	Class I	1982-01-05
K813390	Bondary Single-Use or Gown	The Buckeye Cellulose Corp.	FYA	Class II	1982-01-05
K813377	Ps-Round Surg. Drain & Connector	Pudenz-Schulte Medical Research Corp.	GCY	Class I	1982-01-05
K813368	Disposable Chiba-Type Needle	Dlp, Inc.	GAA	Class I	1982-01-05
K813367	Cuatico Myelography Needles	Dlp, Inc.	GAA	Class I	1982-01-05
K813257	Alveograf Durapatite(18-40 Mesh)	Sterling Drug, Inc.	DZE	Class II	1982-01-05
K812724	Relaxation Tank	Float-To-Relax, Inc.			1982-01-05
K812615	Tm-Capd	Tri-Med, Inc.	KPP	Class II	1982-01-05
K812322	Arizona Radio Capitellar Total Elbow	Zimmer GmbH	JDB	Class II	1982-01-04
K813540	A Fluorometer	American Diagnostic Corp.	KHO	Class I	1981-12-31
K813539	Gentamicin Fluorescent Immunoassay	American Diagnostic Corp.	LCQ	Class II	1981-12-31
K813538	Phenytoin Fluorescent Immunoassay	American Diagnostic Corp.	LES	Class II	1981-12-31
K813536	Astra Total Protein Reagent	Hi Chem, Inc.	CEK	Class II	1981-12-31
K813529	Dade Colorimetric Amylase	American Dade	CIJ	Class II	1981-12-31
K813525	In Vitro Diagnostic Radioimmunoassay	Micromedic Systems	JLW	Class II	1981-12-31
K813524	Centidisc	Bel-Art Products	JQC	Class I	1981-12-31
K813523	Electric Self Sterilization Inocul. Loop	Techhnilab Instruments, Inc.	LTB	Class II	1981-12-31
K813517	Blood Gas Analysis, Standards Controls	United Diagnostics, Inc.	CHL	Class II	1981-12-31
K813513	African Green Monkey Blood in Alservers	Dutchland Laboratories, Inc.	LHW	Class I	1981-12-31
K813511	Uric-Acid	Medical Analysis Systems, Inc.	KNK	Class I	1981-12-31
K813509	Metronidazole Diagnostic Discs	Oxoid U.S.A., Inc.	JTO	Class I	1981-12-31
K813505	Flame Photometer Calibration Standards	Fisher Scientific Company L.L.C.	JIS	Class II	1981-12-31
K813496	Ldh-L	Horiba Instruments Incorporated	CFJ	Class II	1981-12-31
K813495	Alt (Sgpt)	Horiba Instruments Incorporated	CKA	Class I	1981-12-31
K813494	Waters Ileal Reservoir Catheter	Waters Instruments, Inc.	KPH	Class I	1981-12-31
K813488	Catheter Regular	Accurate Surgical Instruments Co.	FJS	Class II	1981-12-31
K813487	Catheter Bubble Stand	Accurate Surgical Instruments Co.	FKX	Class II	1981-12-31
K813476	Ohio Volume Incentive Spirometer	Airco/Ohio Medical Products	BWF	Class II	1981-12-31
K813469	Lipid Profile	Bio-Analytics Laboratories, Inc.	CFD	Class I	1981-12-31
K813465	Free T4 Ria Test Set	Ventrex Laboratories, Inc.	CEC	Class II	1981-12-31
K813449	Phe/tyr Kinetic UV Test Set	P-L Biochemicals, Inc.	JNB	Class II	1981-12-31
K813447	Solutions & Buffers for Blood Gas Instr	Rna Medical Corp.	JIS	Class II	1981-12-31
K813441	Piperacillin 100 Mcg. Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1981-12-31
K813437	Pan Set	Sterile Design, Inc.	FRG	Class II	1981-12-31
K813428	Shunt Adapter	Quinton, Inc.	FKN	Class II	1981-12-31
K813427	Ultrachem Gluc-Dh	Harleco	LFR	Class II	1981-12-31
K813415	Urea Nitrogen Reagent Set	Anco Medical Reagents & Assoc.	CDW	Class II	1981-12-31
K813414	Peak Flow Monitor	Biotrine Corp.	BZH	Class II	1981-12-31
K813412	Glucose Enzyme-Color Reagent Set	Diagnostic Specialties	CGA	Class II	1981-12-31
K813407	Air Mattress	Trans World Agency, Inc.	FNM	Class II	1981-12-31
K813403	Flo-Gard 8000 Infusion Pump System	Travenol Laboratories, S.A.	FRN	Class II	1981-12-31
K813395	Cellulose Acetate-Citrate Agar Hemoglo	Helena Laboratories, Corp.	JBD	Class II	1981-12-31
K813388	Hemodialysate	Edlaw Pharmaceuticals, Inc.	KPO	Class II	1981-12-31
K813383	Disposable Trach Swivel Connector	Intec.	BZA	Class I	1981-12-31
K813359	Myco-Immune Tm Histoplasmin Latex Aggl	American Scientific Products	GMJ	Class II	1981-12-31
K813351	Novametrix Navagraph Model 312 Recorder	Novametrix Medical Systems, Inc.	KLK	Class II	1981-12-31
K813344	Post-Auricular Hearing Aid Model Asp-103	Telesonic, Inc.	ESD	Class I	1981-12-31