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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3404 of 3526

510(k) clearances, page 3404 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791112	Libco 1,2,3, Eyeglass Frames	Libco Eyewear, Inc.	HQZ	Class I	1979-06-15
K791060	Rain-X	Sherwood Medical Co.	BZO	Class I	1979-06-15
K791050	Centria T3 Uptake Test Set	Ventrex Laboratories, Inc.			1979-06-15
K791034	Piggyback Breathing Circuit	Vital Signs, Inc.	BZO	Class I	1979-06-15
K791032	Cardiac Catheterization Sheets/packs	Surgikos, Inc.	KKX	Class II	1979-06-15
K791021	Muscle Testing Gun	The Orthodyn Co.	HRW	Class I	1979-06-15
K790973	Lo-Ion	Gamma Biologicals, Inc.	KSG	Class II	1979-06-15
K790957	Histo-Dispenser	Dynatech Laboratories, Inc.	JTC	Class I	1979-06-15
K790956	Histo-Oiler	Dynatech Laboratories, Inc.	JTC	Class I	1979-06-15
K790937	Emit Auto Digoxin Assay	Syva Co.	KXT	Class II	1979-06-15
K790905	Nuclear Sample Reader	Abbott Medical	JJJ	Class I	1979-06-15
K790897	Quad IV Custom Impression Tray	Sted, Inc.	EBH	Class I	1979-06-15
K790866	14 Karat Casting Gold	Williams Gold Refining Co., Inc.	EJT	Class II	1979-06-15
K790831	Antistreptolysin (Aso) Latex Slide Test	Icl Scientific	GTQ	Class I	1979-06-15
K790800	Centria T4 Ria Test Set	Ventrex Laboratories, Inc.	CDX	Class II	1979-06-15
K790791	Electrophoresis Reagent Set, Hdl	Gelman Sciences, Inc.	LBT	Class I	1979-06-15
K790786	Glucose (Hk) Reagent	Gilford Diagnostics	CFR	Class II	1979-06-15
K790773	Enzymatic Triglycerides-S.v.r.	Calbiochem-Behring Corp.	CDT	Class I	1979-06-15
K790772	Chemtab	Boehringer Mannheim Corp.	JIM	Class II	1979-06-15
K790734	Pregnosticon Pregnancy Test Kit	Organon LLC	JHJ	Class II	1979-06-15
K790723	Prophylaxis Cups and Polishers	Young Dental Manufacturing Co 1, LLC.	EHK	Class I	1979-06-15
K790722	Prophylaxis Angle	Young Dental Manufacturing Co 1, LLC.	EGS	Class I	1979-06-15
K790655	Abuscreen Ria for Phencyclidine	Hoffmann-La Roche, Inc.	LCL	Unclassified	1979-06-15
K790653	Nova 3 Chloride/total Dioxide Analyzer	Nova Corp.	CGZ	Class II	1979-06-15
K790611	Osmometer Model 3W11	Advanced Instruments, LLC	JJM	Class I	1979-06-15
K790608	Bl Bilirubinometer	Advanced Instruments, LLC	CIG	Class II	1979-06-15
K790596	Enamel Bond System	Wallace A. Erickson & Co.	EBC	Class II	1979-06-15
K790595	Dental Alginate Impression Material	Wallace A. Erickson & Co.	ELW	Class II	1979-06-15
K790594	Dental Composite Restorative Material	Wallace A. Erickson & Co.	EBF	Class II	1979-06-15
K790593	Dental Cement, Zinc Phosphate	Wallace A. Erickson & Co.	EMA	Class II	1979-06-15
K790592	Impression Material, Rubber	Wallace A. Erickson & Co.	ELW	Class II	1979-06-15
K790584	Ames Tda/gentgmicin	Miles Laboratories, Inc.	DJB	Class II	1979-06-15
K790553	Cholesterol Kit, Hdl-Ds	Beckman Instruments, Inc.	LBS	Class I	1979-06-15
K790401	Phencyclidine Urine Assay	Syva Co.	LCM	Unclassified	1979-06-15
K790400	Urine Negative Calibrator	Syva Co.	DLT	Class II	1979-06-15
K790399	Urine Medium Calibrator	Syva Co.	DLJ	Class II	1979-06-15
K790398	Emit-D.a.u. Phencyclidine Urine Low	Syva Co.	DLJ	Class II	1979-06-15
K772011	Wholey Occlusion Balloon Catheter	Cook, Inc.	FOZ	Class II	1979-06-15
K791047	Nerve Stimulator, Digital Peripheral	C.R. Bard Inc	BXN	Class II	1979-06-13
K791046	Endotracheal Tubes, Long & Short Term	Extracorporeal Medical Specialities, Inc.	BTR	Class II	1979-06-13
K791045	Model Gv-10 Lanz Pressure-Valve	Extracorporeal Medical Specialities, Inc.	BTR	Class II	1979-06-13
K791044	Tracheostomy Tubes, Short and Long Term	Extracorporeal Medical Specialities, Inc.	BTO	Class II	1979-06-13
K791043	Linde Oxygen Concentrator Model Loc-Hc	Union Carbide Corp.	CAW	Class II	1979-06-13
K791042	I.p.p.b. Manifold & Nebulizer, Universal	Airlife, Inc.	CAF	Class II	1979-06-13
K791015	Volurex Tm	Dhd Medical Products Div. Diemolding Corp.	BWF	Class II	1979-06-13
K790938	Saphenous Vein Irrigation, Pressurizatio	Shiley, Inc.	DWP	Class II	1979-06-13
K790464	Fiax Test Kit for Anti-Toxoplasma Antibo	Intl. Diagnostic Technology	GLZ	Class II	1979-06-13
K791092	Esterase-Chloroesterase, Staining Kit	Eureka Laboratories, Inc.			1979-06-12
K791009	Santa Casa Distractor	Depuy, Inc.	KWP	Class II	1979-06-11
K791006	Smart Bilectrodes	Electronics for Medicine, Inc.	DRX	Class II	1979-06-11