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 382 of 3528

510(k) clearances, page 382 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201395	Sterile High-pressure Angiographic Syringes for single-use	Youwo (Guangzhou) Medical Device Co., Ltd.	DXT	Class II	2020-10-28
K200790	LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System	L&K Biomed Co.,Ltd.	NKB	Class II	2020-10-28
K200759	NIM Vital, Nerve Integrity Monitor	Medtronic Xomed, Inc.	GWF	Class II	2020-10-28
K200153	Bright Bond Universal	GENOSS Co., Ltd.	KLE	Class II	2020-10-28
K200125	Thermoforming Sheet Materials	Erkodent Erich Kopp GmbH	MQC	Unclassified	2020-10-28
K200003	NP1 Instrument, Creo Electrosurgical System	Creo Medical Ltd	NEY	Class II	2020-10-28
K193038	Comprehensive Shoulder System	Biomet Manufacturing Corp	MBF	Class II	2020-10-28
K203099	Triathlon PKR System	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	HSX	Class II	2020-10-27
K203005	Mazor X	Mazor Robotics Ltd	OLO	Class II	2020-10-27
K202960	General Cutting Contra Handpiece	Nakanishi Inc.	EGS	Class I	2020-10-27
K202887	IlluminOss Bone Stabilization System	Illuminoss Medical Inc.	QAD	Class II	2020-10-27
K202519	OrthoNext Platform System	Orthofix SRL	LLZ	Class II	2020-10-27
K202152	NextAR TKA Platform	Medacta International SA	SBF	Class II	2020-10-27
K201627	Dental Computed Tomography X-Ray System, Green X	Vatech Co., Ltd.	OAS	Class II	2020-10-27
K200273	FREEPRINT temp	Detax GmbH & Co. KG	EBG	Class II	2020-10-27
K200156	Bright Low Flow	GENOSS Co., Ltd.	EBF	Class II	2020-10-27
K193084	TIB Abutment System	Southern Implants, (Pty.) Ltd.	NHA	Class II	2020-10-27
K202722	1212Fca	Rayence Co., Ltd.	MQB	Class II	2020-10-26
K202528	Cannulated Power Driver Attachment	K2M, Inc	NKB	Class II	2020-10-26
K202489	AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System	Advanced Orthopaedic Solutions, Inc.	HRS	Class II	2020-10-26
K202469	G-EYE System	Smart Medical Systems Ltd.	FDF	Class II	2020-10-26
K202179	Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	LYZ	Class I	2020-10-26
K202065	DOLOMITE Anterior Cervical Stabilization System	Astura Medical	OVE	Class II	2020-10-26
K201811	coraForce and coraFlex Support Catheters	ReFlow Medical, Inc	DQY	Class II	2020-10-26
K200937	ACURA Stabilization System	Indius Medical Technologies Pvt. Ltd.	NKB	Class II	2020-10-26
K200150	Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2020-10-26
K201335	Li-Battery powered OTC TENS/EMS Combination Stimulator	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2020-10-24
K202894	Wiltrom Spinal Fixation System	Wiltrom Corporation Limited	NKB	Class II	2020-10-23
K202797	Drakon and Sequre Microcatheters	Accurate Medical Therapeutics, Ltd.	DQO	Class II	2020-10-23
K202429	Mobio Total Knee System	b-ONE Ortho Corp.	JWH	Class II	2020-10-23
K202392	SIR-Spheres Microspheres Activity Calculator (SMAC)	Sirtex Medical US Holdings, Inc.	KPS	Class II	2020-10-23
K202071	SURGIPHOR Wound Irrigation System	Orthophor, LLC	FQH	Class II	2020-10-23
K201843	Infrared ear and forehead thermometer, model YI-100	Wenzhou Yosun Medical Technology Co., Ltd.	FLL	Class II	2020-10-23
K201824	Nerivio	Theranica Bio-Electronics Ltd.	QGT	Class II	2020-10-23
K200249	Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])	Kitazato Corporation	MQL	Class II	2020-10-23
K200223	PocketDoc™ Micro Wound Therapy System	Pensar Medical	OMP	Class II	2020-10-23
K200109	OXY-1 System	Abiomed, Inc.	DTZ	Class II	2020-10-23
K193556	Cryocheck Hex LA	Precision BioLogic Inc.	GFO	Class II	2020-10-23
K193357	V-Mix	Inter-Med/Vista Dental Products	KJJ	Unclassified	2020-10-23
K193088	MaxZero Extension Sets with Needle-Free Connector(s)	CareFusion 303, Inc	FPA	Class II	2020-10-23
K192811	BenestaTM Tissue Removal Device	Caldera Medical, Inc.	HIH	Class II	2020-10-23
K192317	Planmed Clarity 2D and Clarity S	Planmed Oy	MUE	Class II	2020-10-23
K202948	EzOrtho	Ewoosoft Co., Ltd	LLZ	Class II	2020-10-22
K202817	GEO Bone Screw System	Gramercy Extremity Orthopedics, LLC.	HWC	Class II	2020-10-22
K202428	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	Lumenis Ltd	GEX	Class II	2020-10-22
K202180	Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001	Axess Vision Technology	EOQ	Class II	2020-10-22
K201768	Voluson E10	GE Healthcare	IYN	Class II	2020-10-22
K200318	UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece	Karl Storz Endoscopy-America, Inc.	ERL	Class II	2020-10-22
K193623	DIOnavi-Denture	Dio Corporation	EBI	Class II	2020-10-22
K202799	Eva15	Palliare	HIF	Class II	2020-10-21