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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 672 of 3530

510(k) clearances, page 672 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152450	Esophageal Cooling Device	Advanced Cooling Therapy, LLC	PLA	Class II	2016-01-15
K152134	Reprocessed Vessel Sealer	Sterilmed Inc	NUJ	Class II	2016-01-15
K151848	Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System	Zimmer GmbH	JDQ	Class II	2016-01-15
K151794	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2016-01-15
K151661	Renovo Life Hard Carbon Coated Drill Bit	Renovo Life, LLC	HTW	Class I	2016-01-15
K151491	Falck Medical Multifunction Tonometer, FAT1	Falck Medical Corporation	HKY	Class II	2016-01-15
K151320	BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml	Becton Dickinson & Co	LON	Class II	2016-01-15
K151269	ECG Mini System Continuous ECG Monitor and Arrhythmia Detector	Lifewatch Technologies, Ltd.	DSI	Class II	2016-01-15
K151228	PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm	Emerson & Co. S.r.l.	KGO	Class I	2016-01-15
K151081	MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge	Cardica, Inc.	GDW	Class II	2016-01-15
K151075	BR-ABVS Viewer 1.0	Taihao Medical, Inc.	LLZ	Class II	2016-01-15
K150409	VIVACE Electrosurgical System	Sung Hwan E&B Co.,Ltd	OUH	Class II	2016-01-15
K143153	Evis Exera II Duodenovideoscope Olympus Tjf Type Q180v	Olympus Medical Systems Corp.	FDT	Class II	2016-01-15
K153601	Spectra Optia Apheresis System	Terumobct, Inc.	LKN	Unclassified	2016-01-14
K153591	ebb Complete Tamponade System	Clinical Innovations, LLC	OQY	Class II	2016-01-14
K153466	PillCam COLON 2 Capsule Endoscopy System	Given Imaging Ltd.	PGD	Class II	2016-01-14
K153356	Spine Innovation Interbody System	Spine Innovation, LLC	MAX	Class II	2016-01-14
K153338	Tiger Cannulated Screw System	Trilliant Surgical LLC	HWC	Class II	2016-01-14
K153025	Turbett Surgical Container	TURBETT SURGICAL, Inc	FRG	Class II	2016-01-14
K152972	Amendia Stand-Alone Cervical System	Spinal Elements, Inc	OVE	Class II	2016-01-14
K152966	Aequalis Fx2	Tornier S.A.S.	PHX	Class II	2016-01-14
K152869	LipiView II Ocular Surface Interferometer	TearScience, Inc.	HKI	Class II	2016-01-14
K152475	FORZA PTC Spacer System	Orthofix SRL	MAX	Class II	2016-01-14
K152361	OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System	Mallinckrodt, Inc.	IZQ	Class II	2016-01-14
K151846	Rainbow LS Pressing	GENOSS Co., Ltd.	EIH	Class II	2016-01-14
K151842	Rainbow Shine	GENOSS Co., Ltd.	EIH	Class II	2016-01-14
K151487	Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method	Diatron US Inc	CFR	Class II	2016-01-14
K151468	ARIX Wrist System	Jeil Medical Corporation	HRS	Class II	2016-01-14
K151141	Cronus HP - High Pressure Peripheral Balloon Catheter	Nipro Medical Corporation	LIT	Class II	2016-01-14
K151039	ATLANTIS Abutment for NobelActive 3.0	Dentsply International, Inc.	NHA	Class II	2016-01-14
K150032	GluStitch Twist Tissue Adhesive	Glustitch, Inc.	MPN	Class II	2016-01-14
K153635	SALVATION(R) External Fixation System	Wrightmedicaltechnologyinc	KTT	Class II	2016-01-13
K153415	Reprocessed Stryker External Fixation Devices	Stryker Sustainability Solutions	KTT	Class II	2016-01-13
K153242	Frontier Medical Devices In-Line Orthopedic Cable Cerclage System	Frontier Medical Devices, Inc.	JDQ	Class II	2016-01-13
K153125	IntraNovo Microcatheter	Texasmedical Technologies, Inc.	DQO	Class II	2016-01-13
K152942	NuVasiveNVM5 System	Nu Vasive, Incorporated	PDQ	Class II	2016-01-13
K152854	S50 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2016-01-13
K152733	FFRct	Heartflow, Inc.	PJA	Class II	2016-01-13
K152684	Nerve Capping Device	Polyganics Innovations BV	JXI	Class II	2016-01-13
K152627	IFS Fixation Scaffold System	Metric Medical Devices, Inc.	HTY	Class II	2016-01-13
K152541	Penumbra System ACE 64 and ACE 68 Reperfusion Catheters	Penumbra Inc.	NRY	Class II	2016-01-13
K152374	Ll TENS 160A, Ll TENS 160B	FUJI Dynamics Limited	NUH	Class II	2016-01-13
K151725	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	Advanced Sterilization Products	MLR	Class II	2016-01-13
K151621	BioHorizons CAD/CAM Abutments	BioHorizons Implant Systems Inc	NHA	Class II	2016-01-13
K151312	VerteLP Interbody Fusion Device	Vgi, LLC	OVD	Class II	2016-01-13
K151070	Sonishield 100 Antimicrobial Ultrasound Gel	Quotient Medical	MUI	Class II	2016-01-13
K150019	TheraVision Ultrasound Ablation System and ACOUSTx Applicators	Acoustic Medsystems, Inc.	NTB	Class II	2016-01-13
K153354	3MP Color LCD Monitor, RadiForce RX350	Eizo Corporation	PGY	Class II	2016-01-12
K153147	Cios Connect	Siemens Medical Solutions USA, Inc.	OWB	Class II	2016-01-12
K153012	Sofia Influenza A+B FIA	Ortho-Clinical Diagnostics, Inc.	PSZ	Class II	2016-01-12