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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 642 of 3529

510(k) clearances, page 642 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160016	Steth IO	Stratoscientific	DQD	Class II	2016-07-15
K153621	Juliet® Ti	Spineart SA	MAX	Class II	2016-07-15
K153097	Belvedere™ Lateral Plating System	Neurostructures, Inc.	KWQ	Class II	2016-07-15
K152294	FDR Visionary Suite	Shimadzu Corp.	KPR	Class II	2016-07-15
K151978	EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control	Edan Instruments, Inc.	CHL	Class II	2016-07-15
DEN150004	EPIC ClearView System	Epic Research & Diagnostics, Inc.	PNA	Class I	2016-07-15
K161072	Powder Free Grey Vinyl Examination Gloves	Zibo Flourish Trading Co., Ltd.	LYZ	Class I	2016-07-14
K160988	Biopor, AOC Porous Polyethylene, Cerepor	Ceremed, Inc.	KKY	Class II	2016-07-14
K160906	Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2016-07-14
K160848	Wingman 18 Crossing Catheter	ReFlow Medical, Inc	DQY	Class II	2016-07-14
K160846	AmplifEYE	Medivators Inc	FED	Class II	2016-07-14
K160613	Soberlink Cellular Device and Sober Sky Web Portal	Soberlink Healthcare LLC	DJZ	Class I	2016-07-14
K160518	LEONI ORION System	Leoni Cia Cable System	JAI	Class II	2016-07-14
K160102	Amber Mill Series and Amber Press Series	Hass Corp.	EIH	Class II	2016-07-14
K160031	Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)	Sunrise Medical, Inc.	ITI	Class II	2016-07-14
K153422	Panpac Disposable Pessary Fitting Set	Panpac Medical Corporation	HHW	Class II	2016-07-14
K153230	ShefaBone SCPC Resorbable Bone Graft	The Implantech Inc./Shefabone	LYC	Class II	2016-07-14
K153087	IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved	Ivy Sports Medicine, LLC	GAT	Class II	2016-07-14
K151790	PMT Platinum Depthalon Depth Electrode	PMT Corp.	GZL	Class II	2016-07-14
K161525	TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2016-07-13
K161419	Multi Modality Viewer	Canon Medical Informatics, Inc.	LLZ	Class II	2016-07-13
K161163	PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory	Hitachi, Ltd.	LHN	Class II	2016-07-13
K160977	PolyDev Soft Contact Lenses	Polydev, Ltd.	LPL	Class II	2016-07-13
K160859	OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)	Contamac Ltd.	MUW	Class II	2016-07-13
K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	CooperVision, Inc.	LPL	Class II	2016-07-13
K160744	LOOK PTFE Suture	Surgical Specialties Corp	NBY	Class II	2016-07-13
K160551	VALO Grand	Ultradent Products Inc.	EBZ	Class II	2016-07-13
K160482	t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater	Tandem Diabetes Care, Inc.	LZG	Class II	2016-07-13
K160431	ActiveCare Home	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2016-07-13
K152952	E-Cath	Pajunk GmbH Medizintechnologie	BSO	Class II	2016-07-13
K152764	Exactech Gps	Blue Ortho	HAW	Class II	2016-07-13
K161726	E-Pack Procedure Kit	Ethicon, Inc	GAM	Class II	2016-07-12
K161640	Penumbra System ACE 68 Reperfusion Catheter	Penumbra Inc.	NRY	Class II	2016-07-12
K161337	CryoDose H or Similar	Nuance Medical, LLC	GEH	Class II	2016-07-12
K161175	Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL	Liofilchem S.r.l.	JWY	Class II	2016-07-12
K161055	Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15	FUJI Dynamics Limited	KPI	Class II	2016-07-12
K160448	Artline	Health Line International Corporation	DQY	Class II	2016-07-12
K160123	Apinator	Allen J. Moses, Dds, Ltd.	LRK	Class II	2016-07-12
K160077	RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set	Jbw7 Innovations, LLC	LJE	Unclassified	2016-07-12
K153568	InMode Plus System	Inmode MD, Ltd.	PBX	Class II	2016-07-12
K153325	Gradia Plus	GC America Inc.	EBF	Class II	2016-07-12
K152803	Sungshim Sterile Single Use Insulin Syringe	Sung Shim Medicare Co., Ltd.	FMF	Class II	2016-07-12
K161685	syngo®.via protoNeo (Version VA10A)	Siemens Healthcare GmbH	LLZ	Class II	2016-07-11
K161271	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2016-07-11
K161149	PASS OCT Spinal System	Medicrea International	NKG	Class II	2016-07-11
K160875	Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating	Medtronic, Inc.	KGO	Class I	2016-07-11
K160758	PeriCoach OTC	Analytica, Ltd.	HIR	Class II	2016-07-11
K153786	Prow Fusion-V	Nlt Spine, Ltd.	MAX	Class II	2016-07-11
K153105	MLX™ - Medial Lateral Expandable Lumbar Interbody System	Nu Vasive, Incorporated	MAX	Class II	2016-07-11
K153055	ACE Electrosurgical Resection and Vaporization Electrodes Series	Ace Medical Devices Pvt. Ltd	GEI	Class II	2016-07-11