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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 738 of 3530

510(k) clearances, page 738 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142419	Mini and Micro Fragments Reconstruction System-NEOFIX	Neoortho Productos Orthopedicos S/A	HRS	Class II	2014-12-16
K142108	Rt Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis	Brainlab, Inc.	MUJ	Class II	2014-12-16
K141775	Sofia (R) Strep a+ Fia	Ortho-Clinical Diagnostics, Inc.	GTY	Class I	2014-12-16
K141295	Merit Hydrophilic Guidewire	Merit Medical Systems, Inc.	DQX	Class II	2014-12-16
K141009	Fort Defiance Automated Steam Sterilizer	Fort Defiance Industries, LLC	FLE	Class II	2014-12-16
K140860	ImmersiveTouch3 and MicrovisTouch	ImmersiveTouch, Inc.	LLZ	Class II	2014-12-16
K143330	BruxZir Anterior	Prismatik Dentalcraft, Inc.	EIH	Class II	2014-12-15
K143244	The Panthera Anti-Snoring Device	Panthera Dental Inc	LRK	Class II	2014-12-15
K142643	Stabilynx PEEK Suture Anchor	D3 Dc, LLC /Stabilynx, Inc.	MBI	Class II	2014-12-15
K142490	ProxiFuse Hammer Toe Device	Cartiva, Inc.	HWC	Class II	2014-12-15
K142477	Intact Advance and Intact Excision XL, Intact BLES	Intact Medical Corporation	KNW	Class II	2014-12-15
K142329	Bbs Revolution	Dbmedx, Inc.	IYO	Class II	2014-12-15
K141575	Plac Test for Lp-Pla2 Activity	Diadexus, Inc.	NOE	Class II	2014-12-15
K141513	Instru-Safe Instrument Protection System	Summit Medical, LLC	KCT	Class II	2014-12-15
K141330	Endo-Cord	Enroxtech, Inc.	FST	Class II	2014-12-15
K140734	Nextgen Altius Oct System	Ebi, LLC	KWP	Class II	2014-12-15
K140667	Well Lead Hydrophilic Silicone Foley Catheter	Well Lead Medical Co. Ltd	EZL	Class II	2014-12-15
K140593	Advance Salivary Balloon Catheter with Wire Guide	Cook Inc.	GCJ	Class II	2014-12-15
DEN140010	Perkinelmer Enlite Neonatal Trec Test System	Wallac Oy	PJI	Class II	2014-12-15
K142975	Bovie Ultimate High Frequency Electrosurgical Generator	Apyx Medical Corporation	GEI	Class II	2014-12-12
K142620	0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe	Excelsior Medical LLC	NGT	Class II	2014-12-12
K142384	DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)	Qualimed SRL	LPL	Class II	2014-12-12
K142180	Telesense	Scottcare Corporation	DSI	Class II	2014-12-12
K142132	Pool Norm	Diagnostics Stago S.A.S.	GGN	Class II	2014-12-12
K142081	Contrast Monitoring System Display, Contrast Monitoring System Syringes	Osprey Medical, Inc.	DXT	Class II	2014-12-12
K141756	Infinity Explorer Software, C700 for It Patient Vicinity Workstation	Draeger Medical Systems, Inc.	MSX	Class II	2014-12-12
K141304	Yongxin Nitrile Powder Free Patient Examination Gloves, Blue Color	Yongxin Healthcare Co., Ltd.	LZA	Class I	2014-12-12
K141303	Zhida Nitrile Powder Free Patient Examination Gloves, Blue Color	Zhida Glove Co., Ltd.	LZA	Class I	2014-12-12
K140797	Ipacs Medical Image Management System	Visbion Limited	LLZ	Class II	2014-12-12
K140680	Leadpoint Focus Workststion, Leadpoint Focus Notebook System	Alpine Biomed ApS	GZL	Class II	2014-12-12
K140663	Therasnore	Distar, Inc.	LRK	Class II	2014-12-12
K140350	Vella 5% Sodium Fluoride Varnish with Nufluor and Xylitol	Preventive Technologies, Inc.	LBH	Class II	2014-12-12
K140202	Trausim Dental Implant System	Jiangsu Trausim Medical Instrument Co.,Ltd.	DZE	Class II	2014-12-12
K140091	Xpeed Anyridge Internal Implant Sysyem	Megagen Implant Co., Ltd.	DZE	Class II	2014-12-12
K133795	Summed Inflation Device Kit	Sunny Medical Device (Shenzhen) Co., Ltd.	MAV	Class II	2014-12-12
K142800	Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard	Co-Innovation Biotech Co.,Ltd.	DKZ	Class II	2014-12-11
K142661	Bi-Portal Bone Graft Delivery Device	Spinal Surgical Strategies, Inc	FMF	Class II	2014-12-11
K142607	AngioVac Circuit	Boston Scientific Corporation	DWE	Class II	2014-12-11
K142560	Varian Head Frame	Varian Medical Systems, Inc.	IYE	Class II	2014-12-11
K142404	iTotal Posterior Stabilized (PS) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2014-12-11
K142146	Ibis Pedicle Screw System	Ortho Development Corp.	NKB	Class II	2014-12-11
K141389	Sapphire Infusion Pump	Q Core Medical, Ltd.	FRN	Class II	2014-12-11
K141053	Ovine Tissue Matrix(otm)	Tela Bio, Inc.	FTM	Class II	2014-12-11
K140669	G7 Osseoti Acetublar Shells	Zimmer GmbH	LPH	Class II	2014-12-11
K143254	eSie Apps Suite	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-12-10
K143206	AmpliVue Bordetella Assay	Ortho-Clinical Diagnostics, Inc.	OZZ	Class II	2014-12-10
K143125	Orthofix True Lok Hexapod System VI.3	Orthofix SRL	KTT	Class II	2014-12-10
K142951	MD210C3 21.3 Diagnostic Imaging LCD Monitor	Nec Display Solutions, Ltd.	PGY	Class II	2014-12-10
K142683	12 mm Endoscopes and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2014-12-10
K142343	Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)	Tangshan Hongyun Plastic Products Co., Ltd.	LYZ	Class I	2014-12-10