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 1461 of 3531

510(k) clearances, page 1461 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030813	Primary Care Solutions Prefilled 10Cc and Prefilled 30Cc Inflation Syringes with Sterile Water Catalog Numbers 1010 and	Primary Care Solutions, Inc.	EZL	Class II	2003-05-30
K030726	Gish Capvrf44 Hardshell Venous Reservoir with Gbs Coating	Gish Biomedical, Inc.	DTN	Class II	2003-05-30
K030661	Stryker Painpump2	Stryker Corp.	MEA	Class II	2003-05-30
K030593	Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B), (Acofilcon a), (Acofilcon B) Soft Contac	X-Cel Contacts, A Walman Co.	LPL	Class II	2003-05-30
K030587	External Counterpulsation (Ecp) Model US-Ecp	S-Tct Health, Inc.	DRN	Class II	2003-05-30
K023887	Inion Otps Biodegradable Mini Plating System	Inion Oy	HWC	Class II	2003-05-30
K021557	Spectrum Silicone Catheter	Cook Inc.	FOZ	Class II	2003-05-30
K013486	Vapotherm 2000H	Vapotherm Inc.	BTT	Class II	2003-05-30
K031481	The Philips Intellivue Mp60, Mp70, and Mp90 Patient Monitors, Release A.20	Philips Medizin Systeme Boblingen GmbH	MHX	Class II	2003-05-29
K031286	Safil and Safil Quick Synthetic Absorbable Surgical Suture	Aesculap Inc	GAM	Class II	2003-05-29
K031172	Spirit III Totalsense Cardiac Coil	GE Healthcare Coils	MOS	Class II	2003-05-29
K031143	Alpha 5000 Wrist Coil	GE Healthcare Coils	MOS	Class II	2003-05-29
K031139	Premier III Phased Array Ctl Spine Coil	GE Healthcare Coils	MOS	Class II	2003-05-29
K031011	Ligasure 5Mm Laparoscopic Sealer-Divider, Model Ls1500	Medtronic, Inc.	GEI	Class II	2003-05-29
K030781	Kodak Directview Pacs/image Management System, Kodak Directview Workflow Manager,kodak Directview Cx/dx, Kodak Directvib	Eastman Kodak Company	LLZ	Class II	2003-05-29
K030751	Ipacs Prism	Realtimeimage, Inc.	LLZ	Class II	2003-05-29
K030699	Veraviewepocs Panoramic/cephalometric X-Ray Unit with Cephalometric	J. Morita Mfg. Corp.	EAG	Class II	2003-05-29
K030663	Tokuyama Sofreliner Tough	Tokuyama Dental Corporation	EBI	Class II	2003-05-29
K024278	Paceart System	Medtronic, Inc.	DPS	Class II	2003-05-29
K022274	Carecompanion Patient Station & Nurse Station	Neptec Design Group, Ltd.	DRG	Class II	2003-05-29
K031219	Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)	Orthofix SRL	HSB	Class II	2003-05-28
K031148	In-Vision Imaging System	Jomed, Inc.	DXK	Class II	2003-05-28
K030667	Encore Anterior Spinal Staple System	Encore Medical, LP	KWQ	Class II	2003-05-28
K023662	Prosonic Ultraviolet Toothbrush Sanitizer	Hwadong International Company, Ltd.	MCF	Class I	2003-05-28
K023068	Papillon Mask Set	Map Medizintechnik Fur Arzt und Patient GmbH	BZD	Class II	2003-05-28
K022448	Water Purification System	Purity Water Company of San Antonio, Inc.	FIP	Class II	2003-05-28
K031610	Rex Medical Cleaner Rotational Thrombectomy System	Rex Medical LP	MCW	Class II	2003-05-27
K030884	Aptus Blue	Acadental	KJJ	Unclassified	2003-05-27
K030618	Wilson-Cook Celiac Plexus Neurolysis Needle	Wilson-Cook Medical Inc.	BSP	Class II	2003-05-27
K030612	Genesis II Total Knee System	Smith & Nephew, Inc.	MBH	Class II	2003-05-27
K023937	Cook Vascular Serpenta Coronary Sinus Introducer System	Cook Vandergrift, Inc.	DYB	Class II	2003-05-27
K012889	Banicide Liquid Chemical Sterilant/high-Level Disinfectant	Pascal International, Inc.	MED	Class II	2003-05-27
K031514	Modification to Trupeak Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	2003-05-23
K031371	Saphyre Bipolar Ablation Probes	Smith & Nephew, Inc.	GEI	Class II	2003-05-23
K031361	Cadd High-Volume Administration Sets with Flowstop	Abbott Medical	FPA	Class II	2003-05-23
K031344	Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (Gss) Needle	Ranfac Corp.	KNW	Class II	2003-05-23
K031262	Endoscopic Plication System, Model 160-00760	Ndo Surgical, Inc.	ODE	Class II	2003-05-23
K031217	Gmrs Press Fit Stems with Purefix Ha	Howmedica Osteonics Corp	LZO	Class II	2003-05-23
K031209	Ge 1.5T 8 Channel Torso Coil	GE Healthcare	MOS	Class II	2003-05-23
K031171	Disposable Powdered Vinyl Synthetic Exam Gloves	Synmertex Co, Ltd.	LYZ	Class I	2003-05-23
K031120	Disposable Powder Free Vinyl Synthetic Exam Gloves	Synmertex Co, Ltd.	LYZ	Class I	2003-05-23
K031117	Seednet System and Seednetgold System	Galil Medical Ltd.	GEH	Class II	2003-05-23
K031076	Disposable Powder Free Vinyl Synthetic Exam Gloves White Color	Synmertex Co, Ltd.	LYZ	Class I	2003-05-23
K030956	Navigator Ureteral Access Sheath Set	Boston Scientific Corporation	FED	Class II	2003-05-23
K030930	Oximax Softcare Sensors, Models Sc-a, Sc-Pr, Sc-Neo, Sc-N	Medtronic, Inc.	DQA	Class II	2003-05-23
K030889	Ultraekogel Models Ek 2000 & Ek 2001	Inmed Ltda.	MUI	Class II	2003-05-23
K030827	Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204	Orthosoft, Inc.	HAW	Class II	2003-05-23
K030728	Fyrelink Vl	Mpacs, LLC	LLZ	Class II	2003-05-23
K030712	Amsure Urethral Catheterization Tray	Amsino International, Inc.	FCM	Class II	2003-05-23
K030664	Amsure Foley Insertion Tray	Amsino International, Inc.	FCM	Class II	2003-05-23