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 1338 of 3531

510(k) clearances, page 1338 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033577	Uniscan, Pulmoscan, Pulmoscan Radiographic Systems	Medlink Imaging, LLC.	KPR	Class II	2005-03-18
K050559	Ge Discovery Vct System	GE Healthcare	KPS	Class II	2005-03-17
K050535	Stryker Mmf Screw	Stryker Corp.	DZL	Class II	2005-03-17
K050366	Imagenpro	Cardiovascular Imaging Technologies, LLC	KPS	Class II	2005-03-17
K050346	Stabilization Screw	New Deal, S.A.	HWC	Class II	2005-03-17
K050255	Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4	Gendex Corp.	EHD	Class II	2005-03-17
K050212	Personal Warming Jelly	Qualis, Inc.	NUC	Class II	2005-03-17
K050211	Personal Warming Gel	Qualis, Inc.	NUC	Class II	2005-03-17
K050195	V-Bag with Gbs Coating	Gish Biomedical, Inc.	DTN	Class II	2005-03-17
K050084	Cosman RF Lesion Generator, Model Rfg-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;	Boston Scientific Neuromodulation Corporation	GXI	Class II	2005-03-17
K043451	Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator	Hyphen Biomed Sasu	GGN	Class II	2005-03-17
K043436	Nxstage Dialysate Preparation Module, Model Nx0269	NxStage Medical Inc	FKR	Class II	2005-03-17
K040262	Dbx Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2005-03-17
K050530	Polymer Coated Powder Free Nitrile Examination Gloves (Blue,white,violet, Pink,green)	Spi Gloves Sdn. Bhd.	LZA	Class I	2005-03-16
K050529	Polymer Coated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Toter	Spi Gloves Sdn. Bhd.	LYY	Class I	2005-03-16
K050359	Ultra Mirage II Mask	ResMed Corp	BZD	Class II	2005-03-16
K050316	Aequalis Reversed Shoulder Prosthesis	TORNIER Inc.	PHX	Class II	2005-03-16
K050214	Nitrile Powder Free Examination Gloves (White)	Hartalega Sdn Bhd	LZA	Class I	2005-03-16
K050184	Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove	Regent Medical Americas, LLC	KGO	Class I	2005-03-16
K050091	Tripter-X1 Compact Duet Sp (Separated Pulse)	Direx Systems Corp.	LNS	Class II	2005-03-16
K043491	Enfanttm	Diopsys Inc	GWE	Class II	2005-03-16
K043401	Spectranetics Lld Cs, Model 518-039	Spectranetics Corp.	DRB	Class II	2005-03-16
K043292	Hemocath	Med-Conduit, Inc.	MSD	Class II	2005-03-16
K043021	Stryker Ureteroscope	Stryker Corp.	FGB	Class II	2005-03-16
K043004	Stackhouse Freedomaire II Surgical Helmet System, Models 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031	Viasys Medsystems	FYA	Class II	2005-03-16
K042901	Endomark Sterile India Ink	PMT Corp.	NBG	Class II	2005-03-16
K042899	Synthes (USA) Ria System - Expanded Indications	Synthes (USA) Products LLC	HTO	Class I	2005-03-16
K042699	Ability Power Gurney	Gator Custom Mobility, Inc.	ITI	Class II	2005-03-16
K042344	Excia Total Hip System	Aesculap Inc	LWJ	Class II	2005-03-16
K041626	Immunocard Stat! Flu a & B	Meridian Bioscience Inc	PSZ	Class II	2005-03-16
K041541	Compel Mlr Surgical Gowns	Standard Textile Co., Inc.	FYA	Class II	2005-03-16
K033436	Reprocessed Diagnostic Ultrasound Catheter	Alliance Medical Corp.	OWQ	Class II	2005-03-16
K032666	Medline Sterile Disposable Surgical Gowns/drapes	MEDLINE INDUSTRIES, LP - Northfield	KKX	Class II	2005-03-16
K050378	Synthes Mandible External Fixator	Synthes (USA) Products LLC	MQN	Class II	2005-03-15
K050362	Vita Pm 7 (20 Gram Bottles), Vita Pm 7 (50 Gram Bottles)	Vident	EIH	Class II	2005-03-15
K050245	Cellsearch Circulating Tumor Cell Kit	Veridex, LLC	NQI	Class II	2005-03-15
K050206	Cedia Tacrolimus Assay	Microgenics Corporation	MLM	Class II	2005-03-15
K050145	Celltracka Analyzer II	Immunicon Corp.	NQI	Class II	2005-03-15
K050112	Pro Fit Disposable Rectal Speculum, Models 8116 and 8117	Prime Pacific Health Innovations Corporation	KPL	Class II	2005-03-15
K043458	Bd Phoenix Automated Microbiology System - Cefotetan (Gn) 2-64 Ug/ml	Becton Dickinson & Co	LON	Class II	2005-03-15
K043317	Omnilux Plus	Photo Therapeutics Limited	ILY	Class II	2005-03-15
K043022	Stryker Flexible Cystonephroscope	Stryker Corp.	FAJ	Class II	2005-03-15
K040883	Evotech Integrated Endoscope Disinfection System	Advanced Sterilization Products	FEB	Class II	2005-03-15
K050501	Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System	Abbott Vascular	FGE	Class II	2005-03-14
K050492	Integra Bone Fixation System	Integra LifeSciences Corporation	HRS	Class II	2005-03-14
K050457	Merete Metafix Small Fragment Bone Plate System	Merete GmbH	KTT	Class II	2005-03-14
K050412	Vapormax	Trimedyne, Inc.	GEX	Class II	2005-03-14
K050390	Tamarack Anterior Thoracolunbar	Alphatec/Nexmed	KWQ	Class II	2005-03-14
K050361	Modification to Concerto Bipolar Needle Electrode	Boston Scientific Corporation	GEI	Class II	2005-03-14
K050344	Ligaclip 5 M/l Mm Endoscopic Multiple Clip Applier	Ethicon Endo-Surgery Inc	FZP	Class II	2005-03-14