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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 415 of 3528

510(k) clearances, page 415 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191868	iCEWav Neuromonitoring Platform	Ice Neurosystems, Inc.	GWQ	Class II	2020-03-31
K191860	Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential	Semperit Technische Produkte Gesellchaft M.B.H.	KGO	Class I	2020-03-31
K183086	da Vinci X and Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2020-03-31
K200040	Universal Base Conical Connection (CC)	Nobel Biocare AB	NHA	Class II	2020-03-30
K193541	NuVasive Cohere Thoracolumbar Interbody System	Nu Vasive, Incorporated	MAX	Class II	2020-03-30
K193487	Agilon Strip	Biogennix, LLC	MQV	Class II	2020-03-30
K193144	T-Line Hernia Mesh	Deep Blue Medical Advances, Inc.	FTL	Class II	2020-03-30
K192640	Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump	Guangzhou Yongyi Industrial Co., Ltd.	HGX	Class II	2020-03-30
K192490	Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch	Teleflex Medical	GAT	Class II	2020-03-30
K173590	System 83 Plus Washer/Disinfector	Wassenburg Medical B.V.	FEB	Class II	2020-03-30
K200499	QuickDraw Venous Cannula	Edwards Lifesciences LLC	DWF	Class II	2020-03-29
K200494	CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES	GE Healthcare	MHX	Class II	2020-03-29
K192039	Torc Body	Johari Digital Healthcare, Ltd.	NGX	Class II	2020-03-29
K192852	MRI ECG Patient Cable	Ivy Biomedical Systems, Inc.	LNH	Class II	2020-03-28
K200548	CUBEScan BioCon-1100	MCUBE TECHNOLOGY Co.,Ltd.	IYO	Class II	2020-03-27
K200482	StimRouter Neuromodulation System	Bioness, Inc.	GZF	Class II	2020-03-27
K200294	GrandioSO Light Flow	Voco GmbH	EBF	Class II	2020-03-27
K200140	Silhouette Instalift	Sinclair Pharma US, Inc.	GAM	Class II	2020-03-27
K193656	SkyPulse	Fotona d.o.o.	GEX	Class II	2020-03-27
K193200	uMR Omega	Shanghai United Imaging Healthcare Co., Ltd.	LNH	Class II	2020-03-27
K193052	HBP6 Settable, Resorbable Hemostatic Bone Paste	Orthocon, Inc.	MTJ	Unclassified	2020-03-27
K192389	TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)	Medtronic, Inc.	FTL	Class II	2020-03-27
K192240	RAPIDPoint 500e Blood Gas System	Siemens Healthcare Diagnostics Inc.	CHL	Class II	2020-03-27
K192056	JJ Series Container System	Aesculap Inc	KCT	Class II	2020-03-27
K191912	BiWaze Cough	Abmrc, LLC	NHJ	Class II	2020-03-27
K191900	Single Use Grasping Forceps	Zhejiang Chuangxiang Medical Technology Co., Ltd.	OCZ	Class II	2020-03-27
K191401	PregSense	Nuvo- Group, Ltd.	LQK	Class II	2020-03-27
K190091	Diapaste	Diadent Group International	KIF	Class II	2020-03-27
K200456	Becker External Drainage and Monitoring System	Medtronic, Inc.	GWM	Class II	2020-03-26
K200108	GEO 1st MTP Joint Arthrodesis Plating System	Gramercy Extremity Orthopedics, LLC.	HRS	Class II	2020-03-26
K193652	AbClose - Port Site Closure Device	Medeon Biodesign, Inc.	OCW	Class II	2020-03-26
K193639	APTUS® Foot 2.8-3.5 System	Medartis AG	HRS	Class II	2020-03-26
K193633	APTUS® Ankle Trauma System 2.8/3.5	Medartis AG	HRS	Class II	2020-03-26
K193518	Kosmos	Echonous Inc	IYN	Class II	2020-03-26
K193143	Stryker Facial iD Plating System	Stryker Corp.	JEY	Class II	2020-03-26
K193136	Stryker Customized Mandible Recon Plate Kit	Stryker Corp.	JEY	Class II	2020-03-26
K193108	Bonecam Suture Anchor	Valeris Medical	MBI	Class II	2020-03-26
K193053	Tina-quant Hemoglobin A1cDx Gen.3	Roche Diagnostics Operations (Rdo)	PDJ	Class II	2020-03-26
K192987	Aina HbA1c Monitoring System 2	Jana Care, Inc.	LCP	Class II	2020-03-26
K192951	Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun	Ellipse A/S	GEX	Class II	2020-03-26
K192886	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	Volcano Corporation	DQX	Class II	2020-03-26
K192732	BodyGuardian Remote Monitoring System	Preventice Technologies, Inc.	DSI	Class II	2020-03-26
K192724	Propeller Sensor for Symbicort	Reciprocal Labs Corporation	CAF	Class II	2020-03-26
K191830	gammaCore Sapphire	Electrocore, Inc.	PKR	Class II	2020-03-26
K191749	TIGR Matrix Surgical Mesh, TIGR Surgical Mesh	Novus Scientific AB	OWT	Class II	2020-03-26
K191558	Konan Specular Microscope XVII	Konan Medical, Inc.	NQE	Class II	2020-03-26
K200515	syngo.CT Cardiac Planning	Siemens Medical Soultions USA, Inc.	JAK	Class II	2020-03-25
K200241	TempSure System	Cynosure, LLC	PBX	Class II	2020-03-25
K193667	Shapiro MD model laser 272	Conversion Labs, Pr, LLC	OAP	Class II	2020-03-25
K193661	LightWalker Laser System Family	Fotona d.o.o.	GEX	Class II	2020-03-25