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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1578 of 3531

510(k) clearances, page 1578 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013042	Discovery Elbow	Biomet Orthopedics, Inc.	JDC	Class II	2001-10-10
K012464	Helix Hydro-Jet	Andreas Pein Medizintechnik GmbH	FQH	Class II	2001-10-10
K012354	Snowpost, Snowlight	Danville Materials, Inc.	ELR	Class I	2001-10-10
K012264	Marquette Mac8, Mac Personal, Mac Stress, Model N3043iwc	National Custom Ent., Inc.	DPS	Class II	2001-10-10
K012263	Marquette Eagle Monitor Model 4000, Model N3024	National Custom Ent., Inc.	DPS	Class II	2001-10-10
K012172	Duracon Ps Lipped Tibial Insert	Howmedica Osteonics Corp	JWH	Class II	2001-10-10
K012065	Wiener Lab. Creatinina Cinetica Aa	Wiener Laboratories Saic	JFY	Class II	2001-10-10
K012011	Modification to A620 EEG	Stoelting Co.	HCC	Class II	2001-10-10
K010985	Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L	Gambro Renal Products	KDI	Class II	2001-10-10
K010528	Titanium Cement Restrictor Material Peek	Medtronic Sofamor Danek USA Inc	JDK	Class II	2001-10-10
K991810	Modification to Sensititre Yeastone Mic Susceptibility Test	Trek Diagnostic Systems, Ltd.	NGZ	Class II	2001-10-09
K013296	Moss Miami Spinal Systems	Depuyacromed	MNH	Class II	2001-10-09
K013295	Timx Spinal Systems	Depuyacromed	MNH	Class II	2001-10-09
K013294	Monarch Spinal Systems	Depuyacromed	MNH	Class II	2001-10-09
K013029	Seal-Away Cs Introducer Kit, Models 407514, 407515	Abbott Medical	DYB	Class II	2001-10-09
K012928	Abi Vest Airway Clearance System	Advanced Respiratory	BYI	Class II	2001-10-09
K012906	Animec, Models Am-2S-4 and Am-2S-5	Elltec Co., Ltd.	LGZ	Class II	2001-10-09
K012886	Cbyon System with Image Enhanced Fluoroscopy Module	Cbyon, Inc.	HAW	Class II	2001-10-09
K012518	Trace Scientific Alkaline Phosphatase, Two Part Liquid, Model Tr-113	Thermo Dma, Inc.	CJE	Class II	2001-10-09
K012509	Phoenix Electrolyte Calibration Set for the Dade/behring/behring Dimension Chemistry System	Phoenix Diagnostics, Inc.	JIX	Class II	2001-10-09
K012508	Mu Photonics Pain Therapist	Nu Photonics, Inc.	ILY	Class II	2001-10-09
K012485	Ms-140 All-Round Enhanced Performance Filter; Ms-141 All-Round Enhanced Performance Angled; Ms-142 All-Round/hme Enhance	King Systems Corporation.	CAH	Class II	2001-10-09
K012427	Pharmaethyl Local Pulp and Vitality Testing Agent	Specialites Septodont	EAT	Class II	2001-10-09
K012367	Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D	Nichols Institute Diagnostics	JIT	Class II	2001-10-09
K012230	Phem-Alert	Femtek,Llc.	LNW	Class I	2001-10-09
K011021	Laser 20	YA-Man Ltd.	GEX	Class II	2001-10-09
K010954	Concentric Balloon Guide Catheter, Model 90031	Concentric Medical, Inc.	DQY	Class II	2001-10-09
K010477	Auto-Lock	Auto-Lock	MEG	Class II	2001-10-09
K010016	Melker Cuffed Emergency Cricothyrotomy Catheter	Cook Inc.	BWC	Class II	2001-10-09
K013214	Cerebral Blood Flow Analysis System (Cbp), Model Number Cscp-001A	Toshiba America Medical Systems, In.C	JAK	Class II	2001-10-05
K013142	Diasus	Dynamic Imaging, Inc.	IYO	Class II	2001-10-05
K013039	Inion Cps 2.0 Orthognathic Plate	Inion Oy	JEY	Class II	2001-10-05
K012993	Modification to Precise Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2001-10-05
K012971	Isola Spinal Systems	Depuyacromed	MNH	Class II	2001-10-05
K012629	Always Duets	Procter & Gamble Co.	HHD	Class I	2001-10-05
K012505	Sopro595 Intra Oral Camera	Sopro	EIA	Class I	2001-10-05
K012140	Com-Patch	Apex Medical, Inc.	GXY	Class II	2001-10-05
K011349	Intercostal Lockable-Directable Port	Medcanica, Inc.	DRC	Class II	2001-10-05
K010706	Thinner Resolve Fitness Monitor/body Scale, Health-O-Meter	Measurement Specialties, Inc.	MNW	Class II	2001-10-05
K010127	W & H Assistina	A-dec, Inc.	EFB	Class I	2001-10-05
K003661	Socrates Robotic Telemonitoring System	Computer Motion, Inc.	NEQ	Class II	2001-10-05
K003431	Zeus Robotic Surgical System	Computer Motion, Inc.	GCJ	Class II	2001-10-05
K013034	Modification to: Thermacool Iia	Solta Medical, Inc.	GEI	Class II	2001-10-04
K013014	Block Cement Restrictor (Cr) - Titanium	Medtronic Sofamor Danek	JDK	Class II	2001-10-04
K012967	Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System	Disco-O-Tech Medical Technologies, Ltd.	HSB	Class II	2001-10-04
K012950	Modification to: Medrad Spectris Solaris Mr Injector System	Medrad, Inc.	DXT	Class II	2001-10-04
K012949	Uretex Sup Pubourethral Sling	Sofradim Production	OTN	Class II	2001-10-04
K012923	Arthrex Fiberwire, Usp Size 5, Model Ar-7201	Arthrex GmbH	GAT	Class II	2001-10-04
K012710	Disposable Powdered Vinyl Examination Gloves	Shijiazhuang Brilliance Plastic Co., Ltd.	LYZ	Class I	2001-10-04
K012525	Thermo Dma Fructosamine Assay, Model 7500-135/235	Thermo Dma, Inc.	LCP	Class II	2001-10-04