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 1450 of 3531

510(k) clearances, page 1450 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031550	Reusable Multiple-Patient Lifeshirt with Vivologic Analysis Software	Vivometrics, Inc.	DQK	Class II	2003-07-29
K032007	Glovetex Powder Free Latex Examination Gloves, Blue, Non-Sterile Contains 50 Mcgin or Less of Total Water Extractable Pr	Pt. Wrp Buana Multicorpora	LYY	Class I	2003-07-28
K031969	Depuy Restore Orthobiologic Soft Tissue Implant	Depuy Orthopaedics Inc.	FTM	Class II	2003-07-28
K031881	Airbrush Liposculptor System	Biosculpture Technology, Inc.	QPB	Class II	2003-07-28
K031475	Osseotite Nt Certain Implants	ZimVie US Corp LLC	DZE	Class II	2003-07-28
K030170	Reusable Smartstitch Suture Device, Models Om-8007, Om-8500	Opus Medical, Inc.	OCW	Class II	2003-07-28
K024367	Sinclair Wound and Skin Emulsion	Sinclair Pharmaceuticals Ltd	MGQ	Unclassified	2003-07-28
K032182	Ge Logiq 7, Model 2354858	General Electric Co.	IYN	Class II	2003-07-25
K032147	Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70Xx, 71Xx, 72Xx, 7Xxxx Series	CareFusion 303, Inc	FRN	Class II	2003-07-25
K032059	Modification to Macs Modular Anterior Construct System	Aesculap Inc	KWQ	Class II	2003-07-25
K032052	Uc-Plus Solution Unicondylar Knee	Plus Orthopedics	HRY	Class II	2003-07-25
K031999	Elekta Leksell Stereotactic System with Mr Post Kit	Elekta Instrument AB	HAW	Class II	2003-07-25
K031981	2.4 Smartnail, Models 532416, 532425, 532435, 532445	Linvatec Biomaterials, Ltd.	MAI	Class II	2003-07-25
K031980	Modification to Leksell Stereotactic System	Elekta Instrument AB	HAW	Class II	2003-07-25
K031979	Conmed Integrated Systems Nurses Assistant	Conmed Integrated Systems (Cmis)	FSY	Class II	2003-07-25
K031959	Stryker Plating System Periarticular Plates	Howmedica Osteonics Corp	LXT	Class II	2003-07-25
K031910	Stainless Steel Aquatic Wheelchair	Db Perks & Associates, Ltd.	IOR	Class I	2003-07-25
K031854	Vinyl Exam Gloves, Powder-Free, Yellow	Shanghai Jiawang Industrial Co., Ltd.	LYZ	Class I	2003-07-25
K031776	Mc2x Multi-Stage Venous Cannula	Medtronic Perfusion Systems	DWF	Class II	2003-07-25
K031580	Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove	Green Prospect Sdn Bhd	LZA	Class I	2003-07-25
K031554	S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System	Genzyme Biosurgery	CAC	Class II	2003-07-25
K031500	Excel Primary Solution Set	Exelint Intl. Co.	FPA	Class II	2003-07-25
K031394	American Syringe Company 1Cc and 3Cc Syringe	American Syringe Company	FMF	Class II	2003-07-25
K031328	Recovery Filter System, Model RF-048F	C.R. Bard Inc	DTK	Class II	2003-07-25
K031182	Eli 200+ Audicor	Mortara Instrument, Inc.	DPS	Class II	2003-07-25
K030962	Dpx Series Bravo Duo Bone Densitometer	GE Lunar Corp.	KGI	Class II	2003-07-25
K030912	Thyro Test	Thryotec	JLW	Class II	2003-07-25
K030766	Oxinium Femoral Heads	Smith & Nephew, Inc.	JDI	Class II	2003-07-25
K030221	Mytech / Happy Life Blood Pressure Monitor	Mytech Technology Co., Ltd.	DXN	Class II	2003-07-25
K032174	Wide 3Mp Grayscale Tft Lcd Monitor If2103a	Wide Corporation	LLZ	Class II	2003-07-24
K032081	Kavo Everest Zs-Blank Models, 42, 20, and 60	Kavo America	EIH	Class II	2003-07-24
K032013	Coulter Act 5Diff Al Hematology Analyzer	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2003-07-24
K031998	Model J-5 Mvo-Monitor	Myotronics-Noromed, Inc.	NUW	Class II	2003-07-24
K031986	Ics Medical Chartr Ep with Assr and Chartr Oae Systems	Ics Medical Corp.	EWO	Class II	2003-07-24
K031941	Hoffmann II Compact Baltimore Coupling	Howmedica Osteonics Corp	JEC	Class II	2003-07-24
K031837	Modification to Fortitude Cement Restrictor	Spinal Concepts, Inc.	JDK	Class II	2003-07-24
K031648	Visera Rhino-Laryngovideoscope Olympus Enf Type V	Olympus Optical Co., Ltd.	EOB	Class II	2003-07-24
K031624	Tinnitus Rx	Tinnitus Control, Inc.	KLW	Class II	2003-07-24
K031581	Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated White Color, with Protein Labeling, Contains 50 Microg	Green Prospect Sdn Bhd	LYY	Class I	2003-07-24
K031345	Nobel Direct, Models 30937, 30938	Nobel Biocare Uas, Inc.	DZE	Class II	2003-07-24
K031040	Therifil Bone Filler	Therics, Inc.	MQV	Class II	2003-07-24
K030239	Megatech Scientific Face Mask	Megatech Scientific Pte, Ltd.	FXX	Class II	2003-07-24
K031920	Crosspoint Transaccess Catheter, Model Ta-Xp-001	Trans Vascular Incorporated	ITX	Class II	2003-07-23
K031575	Linical Protein 2 Calibration Verifiers Levels a-E for Olympus Au Analyzers	Cliniqa Corporation	JJY	Class I	2003-07-23
K031512	Emit II Plus Cocaine Metabolite Assay	Siemens Healthcare Diagnostics Inc.	DIO	Class II	2003-07-23
K031459	Rapido Cut-Away Cutter	Boston Scientific Corporation	DQY	Class II	2003-07-23
K031390	Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712	Minimed, Inc.	LGZ	Class II	2003-07-23
K031256	Xsif-1Tq140a Small Intestinal Videoscope	Olympus Opto-Electronics Co., Ltd.	FDA	Class II	2003-07-23
K031222	Scanlube	Sonotech, Inc.	MUI	Class II	2003-07-23
K031173	Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013	Needle Tech Products, Inc.	GDF	Class I	2003-07-23