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 1291 of 3531

510(k) clearances, page 1291 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K053063	Pro-Flow Multipurpose Cannula	Pro-Tech Services, Inc.	CCK	Class II	2005-12-13
K052866	Oxyheal 1000 Monoplace Hyperbaric Chamber	Oxyheal Health Group	CBF	Class II	2005-12-13
K052776	Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models Ar-2257, Ar-Tbd	Arthrex GmbH	HTN	Class II	2005-12-13
K052701	Corolene	Peters Surgical	GAW	Class II	2005-12-13
K052635	Teh Loong Powdered Synthetic Vinyl Patient Examination Gloves, Yellow	Teh Loong Corp.	LYZ	Class I	2005-12-13
K052573	Stardust II	Respironics, Inc.	MNR	Class II	2005-12-13
K052522	Stayhealthy Body Composition Analyzer, Models Bc1 and Bc2	Stayhealthy, Inc.	MNW	Class II	2005-12-13
K052289	Deepwave Neuromodulation Pain Therapy Device	Biowave Corporation	LIH	Class II	2005-12-13
K052258	Vascular Solutions Skyway Support Catheter	Vascular Solutions LLC	DQY	Class II	2005-12-13
K052233	Tracheoscopic Ventilation Tube (Tvt) System	Etview, Ltd.	BTR	Class II	2005-12-13
K051993	Lma Fastrach Ett Single Use	The Laryngeal Mask Co., Ltd.	BTR	Class II	2005-12-13
K051242	Winner Self Seal Sterilization Pouch	Winner Medical (USA), Inc.	KCT	Class II	2005-12-13
K053261	Orthofix Titanium Nailing Systems	Orthofix SRL	HSB	Class II	2005-12-12
K052901	Arthrex Tensionlok	Arthrex GmbH	HRS	Class II	2005-12-12
K052847	Capless Pedicle Screw System	Xtant Medical Holdings, Inc.	MNI	Class II	2005-12-12
K052688	Ellipse Flex Ppt, Model 9Esf7255	Danish Dermatologic Development A/S	GEX	Class II	2005-12-12
K052210	Nuvasive Coroent Extensure System	NuVasive Inc	MQP	Class II	2005-12-12
K052133	Immunoscan Ra Anti-Ccp Test System	Eurodiagnostica	NHX	Class II	2005-12-12
K051926	Limerick Pj's Comfort Jr Portable Electric Breast Pump	Limerick, Inc.	HGX	Class II	2005-12-12
K050921	Easystim Nms-28	Easy Med Instrument Co., Ltd.	IPF	Class II	2005-12-12
K050817	T-Tek	R2 Diagnostics, Inc.	GJA	Class II	2005-12-12
K053349	Hoffmann II Rod to Wire Coupling	Howmedica Osteonics Corp	KTT	Class II	2005-12-09
K053346	Modification to: Dp-9900 Digital Ultrasonic Diagnostic Imaging System, Model Dp-9900	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2005-12-09
K053258	Eub-6500 Diagnostic Ultrasound Scanner	Hitachi Medical Corp.	IYN	Class II	2005-12-09
K053201	Curae'lase Cl1000 Ir Laser System	Curae'Lase, Inc.	ILY	Class II	2005-12-09
K053189	Coonrad/morrey Total Elbow, Model 8105 Series	Zimmer GmbH	JDC	Class II	2005-12-09
K053162	Dextroscope & Dextrobeam	Volume Interactions Pte, Ltd.	LLZ	Class II	2005-12-09
K053157	Automated Hdl Cholesterol Flex Reagent Cartridge, Model Df48a	Siemens Healthcare Diagnostics Inc.	LBS	Class I	2005-12-09
K053120	Sterile Field Saline and Heparin Lock Flush Syringes	Excelsior Medical LLC	FOZ	Class II	2005-12-09
K052941	I-Neb Insight Aad System	Profile Therapeutics PLC	CAF	Class II	2005-12-09
K052804	Breathkey Model G10/breathkey Model G30x	Omega Point Systems, LLC	DJZ	Class I	2005-12-09
K052781	Breformance	Bredent-Products for the Dental Technician Laborat	EBG	Class II	2005-12-09
K052622	Macan Model Mc-4A Dental Electrosurgical Unit	Macan Engineering Co.	EKZ	Class II	2005-12-09
K052615	Medisize Gold	Medisize BV	BTT	Class II	2005-12-09
K052586	A & I Pediatric Wheelchairs, Models Rwal2006-12, Lt3207-12. a & I Bariatric Wheelchairs, Model No. Wcde2611p, Wcde2811p	Taiwan an I Co., Ltd.	IOR	Class I	2005-12-09
K052539	Cook Formula 418 Biliary Stent System	Cook Inc.	FGE	Class II	2005-12-09
K052396	Oxysure Portable Oxygen Generator, Model 615	Oxysure Systems, Inc.	CAW	Class II	2005-12-09
K052340	Du857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System	Alfa Tech Medical Systems, Ltd.	IMG	Class II	2005-12-09
K052208	Glucose Pilot	Tianjin New Bay Bioresearch Co., Ltd.	NBW	Class II	2005-12-09
K052177	Powder Free Sterile Latex Surgical Gloves	Hartalega Sdn Bhd	KGO	Class I	2005-12-09
K051691	Minimate Compressor	Precision Medical, Inc.	BTI	Class II	2005-12-09
K051520	Gambro Polyflux Hemodialyzer, Model 6H	Gambro Renal Products	KDI	Class II	2005-12-09
K051373	Cronus Guidewire, Model 001-001470-1	Stereotaxis Inc	NDQ	Class II	2005-12-09
K051275	Laguna Monoaxial Pedicle Screw System	Allez Spine, LLC	NKB	Class II	2005-12-09
K050933	Fugo Blade for Peripheral Iridotomy, Model M300	Medisurg, Ltd.	NCR	Class II	2005-12-09
K053175	Ameditech Drugsmartcup	Ameditech, Inc.	DKZ	Class II	2005-12-08
K053167	Biopure Mtad Root Canal Cleanser	Dentsply Intl.	KJJ	Unclassified	2005-12-08
K053129	Nexustko Needleless Access Device, Model Nis-5	Nexus Medical, LLC	FPA	Class II	2005-12-08
K052946	Mps Acacia Nerve Block Needle	Mps Acacia	CAZ	Class II	2005-12-08
K052887	Surflo Winged Infusion Set with Needle Protection (Surshield), Model Sv-S23bl35vs	Terumo Europe N.V.	FPA	Class II	2005-12-08