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 1289 of 3531

510(k) clearances, page 1289 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052397	Careo Safety Syringe (3Cc/ml, 5Cc/ml, 10Cc/ml)	Life-Shield Products, Inc.	MEG	Class II	2005-12-22
K052328	Zan Lung-Function Lab	Zan Messgerate GmbH	BZC	Class II	2005-12-22
K051487	Drg Laryngeal Augmentation Implant Device	Doctor'S Research Group, Inc.	KHJ	Class II	2005-12-22
K051257	Adult Cerebral Oximeter, Model 2040	Cas Medical Systems, Inc.	DQA	Class II	2005-12-22
K050843	Axxent Electronic Brachytherapy System	Xoft, Inc.	JAD	Class II	2005-12-22
K050758	Chempaq Xbc Analyzer	Chempaq A/S	GKZ	Class II	2005-12-22
K042404	Lifepak, Model 1000	Physio Control, Inc.	MKJ	Class III	2005-12-22
K053470	Novofine 32G Tip	Novo Nordisk a/S	FMI	Class II	2005-12-21
K053457	Vapormax II	Trimedyne, Inc.	GEX	Class II	2005-12-21
K053404	Lifestent Flexstart Biliary Stent System	Edwards Lifesciences LLC	FGE	Class II	2005-12-21
K053269	Masimo Set Rad-8 Pulse Oximeter	Masimo Corporation	DQA	Class II	2005-12-21
K052956	Nitrile Blue Powder Free Examination Glove	Great Glove Sdn Bhd	LZA	Class I	2005-12-21
K052923	Great Glove Powder Free Vinyl Examination Gloves	Great Glove (China), Inc.	LYZ	Class I	2005-12-21
K052811	Hsiner Jet Nebulizer, Model Hs-31100	Hsiner Co., Ltd.	CAF	Class II	2005-12-21
K052780	Dentaplast Hot, Model 16-Xxx	Bredent-Products for the Dental Technician Laborat	EBI	Class II	2005-12-21
K052170	Seaspine Vbr System	Seaspine, Inc.	MQP	Class II	2005-12-21
K051864	Magstim Rapid2, Magstim Super Rapid2, Models 3004-000, 3005-00	Magstim Inc.	GWF	Class II	2005-12-21
K051694	Clickzip Needle Retractable Safety Syringe	Medical Device Manufacturer (Thailand), Ltd.	MEG	Class II	2005-12-21
K051294	Femtest Endometrial Suction Curette, Model Ft-1	Femspec LLC	HHK	Class II	2005-12-21
K053245	Gp General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter; Biliary Catheter	Uresil, LLC	FGE	Class II	2005-12-20
K053214	Theraknit Garment Electrode	Neurotron Medical	GXY	Class II	2005-12-20
K053203	Myneb Nebulizer, Model Rdd100	Respironics New Jersey, Inc.	CAF	Class II	2005-12-20
K053142	Ambu Mark IV Baby Resuscitator	Ambu A/S	BTM	Class II	2005-12-20
K053089	Ascent Pit & Fissure Sealant	Cao Group, Inc.	EBC	Class II	2005-12-20
K052922	Great Glove Powdered Vinyl Examination Gloves	Great Glove (China), Inc.	LYZ	Class I	2005-12-20
K052889	Vitros Ca 19-9	Fujirebio Diagnostics, Inc.	NIG	Class II	2005-12-20
K052810	Scandius Tritis Tibial Acl Reconstruction System	Scandius Biomedical, Inc.	MBI	Class II	2005-12-20
K052779	Brecomp	Bredent-Products for the Dental Technician Laborat	EBF	Class II	2005-12-20
K052772	Barrierplus Gold Ortho Powder-Free Synthetic Polyisoprene Orthopedic Surgical Gloves	Barriermed Glove Co.	KGO	Class I	2005-12-20
K052700	Pana-Spray	NSK America Corp.	EFB	Class I	2005-12-20
K052467	Brain Viewrx Viewer, Version 1.0	Kyron Clinical Imaging, Inc.	LLZ	Class II	2005-12-20
K052288	Vitalogik	Mennen Medical, Inc.	DSI	Class II	2005-12-20
K052135	Cybersonics Cyberwand Dual Probe Lithotripter	Cybersonics, Inc.	FFK	Class II	2005-12-20
K053262	Ksea Unidrive Ent/neuro/omfs System and Accessories	Karl Storz Endoscopy-America, Inc.	ERL	Class II	2005-12-19
K053100	Estech Cobra Bipolar System	Endoscopic Technologies, Inc.	GEI	Class II	2005-12-19
K053066	Sepramesh Ip Bioresorbable Coating/permanent Mesh	Genzyme Corporation	FTL	Class II	2005-12-19
K052906	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer GmbH	PHX	Class II	2005-12-19
K053435	Ge Voluson I	General Electric Co.	IYN	Class II	2005-12-16
K053330	Architect B12 Calibrators	Abbott Medical	JIT	Class II	2005-12-16
K053256	3M Tegaderm Silver (Ag) Mesh	3M Company	FRO	Unclassified	2005-12-16
K053252	U-Clip Device, Models B140, B160 and B180	Medtronic, Inc.	FZP	Class II	2005-12-16
K053196	Ischemia Albumin Cobalt Binding Test (Acb Test)	Inverness Medical Innovations, Inc.	NJV	Class II	2005-12-16
K053154	Mylab15/20 3D/4d Ultrasound Imaging System	Pie Medical	IYN	Class II	2005-12-16
K053118	Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx	Boston Scientific Corporation	DQY	Class II	2005-12-16
K053116	Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx	Boston Scientific Corporation	DQY	Class II	2005-12-16
K053090	Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator	Siemens Healthcare Diagnostics Inc.	JFM	Class II	2005-12-16
K052990	Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem	Zimmer GmbH	KWY	Class II	2005-12-16
K052974	Warming Liquid Personal Lubricant	Pharmapac, LLC	NUC	Class II	2005-12-16
K052871	Stryker Custom Ti Implant	Stryker Leibinger	GXN	Class II	2005-12-16
K052845	B-Care Powdered Latex Examination Gloves	B-Care Industries Co., Ltd.	OPE		2005-12-16