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 602 of 3529

510(k) clearances, page 602 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163082	6200 Ultrasound System and 6250 Ultrasound System	Esaote S.p.A.	IYN	Class II	2017-03-16
K163003	Y3 Proximal Femoral Plate System	Orthopediatrics Canada ULC	HRS	Class II	2017-03-16
K162880	TIPCAM 1S 3D System	Karl Storz Endoscopy-America, Inc.	GWG	Class II	2017-03-16
K162313	NuVasive Next Generation NVM5 System	Nu Vasive, Incorporated	PDQ	Class II	2017-03-16
K162298	LOCI Total Vitamin D Total Assay, LOCI VITD CAL	Siemens Healthcare Diagnostics Inc.	MRG	Class II	2017-03-16
K162070	Joinix Cannular System	Aju Medical Co., Ltd.	HRX	Class II	2017-03-16
K161840	LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated	Waldemar Link GmbH & Co. KG	LZO	Class II	2017-03-16
K161705	U2 Total Knee System E-XPE products	United Orthopedic Corp.	JWH	Class II	2017-03-16
K161416	Multi-unit Abutment Plus	Nobel Biocare AB	NHA	Class II	2017-03-16
K163572	LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source	LV Liberty Vision	KXK	Class II	2017-03-15
K163364	MOJAVE Expandable Interbody System	K2M, Inc	MAX	Class II	2017-03-15
K162905	SleepWeaver 3D Nasal Mask	Circadiance	BZD	Class II	2017-03-15
K162415	Spectra 9Plus	Uzinmedicare Co., Ltd.	HGX	Class II	2017-03-15
K170127	HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40	Hardy Diagnostics	JTN	Class II	2017-03-14
K163522	FilmArray Warrior Control Panel M290	Maine Molecular Quality Controls, Inc.	PMN	Class II	2017-03-14
K163517	Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL	Liofilchem S.r.l.	JWY	Class II	2017-03-14
K163093	Safety Blood Collection Set	Jiangsu Shenli Medical Production Co., Ltd.	FMI	Class II	2017-03-14
K162960	TotalC-Ram	Itena Clinical	EMA	Class II	2017-03-14
K161880	NIVR58-T kit	Barco N.V.	DXJ	Class II	2017-03-14
K161785	Thd Anopress	Thd SpA	KLA	Class II	2017-03-14
K161598	NobelZygoma 0°	Nobel Biocare AB	DZE	Class II	2017-03-14
K160287	Rapid Barostat Bag (RBB) Pump and Catheter	Mui Scientific	FFX	Class II	2017-03-14
K170116	Thermi Injectable RF Electrodes	Thermi	GEI	Class II	2017-03-13
K170030	Novatech Talcair	Novatech S.A.	GCJ	Class II	2017-03-13
K163563	VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)	bioMerieux, Inc.	LON	Class II	2017-03-13
K163039	ORTHOLOC® 3Di Small Bones Plating	Wrightmedicaltechnologyinc	HRS	Class II	2017-03-13
K162921	Navigated Instrument System	Orthofix SRL	OLO	Class II	2017-03-13
K162836	FUJIFILM Surgical System	Fujifilm New Development U.S.A., Inc.	GCJ	Class II	2017-03-13
K162654	mollosil plus	Detax GmbH & Co. KG	EBI	Class II	2017-03-13
K162429	ZipE Knotless Tissue Repair and Attachment Devices	Ziptek LLC	MAI	Class II	2017-03-13
K163152	PROLENE Soft Polypropylene Mesh	Ethicon, Inc	FTL	Class II	2017-03-11
K170512	Altus Spine Titanium Interbody Fusion System	Altus Partners	MAX	Class II	2017-03-10
K170508	EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads	Intuitive Surgical, Inc.	NAY	Class II	2017-03-10
K170336	BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector	Becton Dickinson & Co	FOZ	Class II	2017-03-10
K170084	InterLock Trocar	Fujifilm New Development U.S.A., Inc.	GCJ	Class II	2017-03-10
K163629	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific Ltd.	JJY	Class I	2017-03-10
K163495	AdvanCE capsule endoscope delivery device	United States Endoscopy Group, Inc.	NEZ	Class II	2017-03-10
K163474	CAVUX CervicalCage-L SA System	Providence Medical Technology, Inc.	OVE	Class II	2017-03-10
K163376	Mikro-Cath Pressure Catheter	Millar LLC.	DXO	Class II	2017-03-10
K162935	Rapid2 Therapy System	Magstim Inc.	OBP	Class II	2017-03-10
K162793	RHYTHMIA HDx Mapping System	Boston Scientific Corporation	DQK	Class II	2017-03-10
K162733	iFuse Implant System® - iFuse-3D implant	SI-Bone, Inc.	OUR	Class II	2017-03-10
K162589	Adscope 658 Electronic Stethoscope	American Diagnostic Corp.	DQD	Class II	2017-03-10
K162509	Infrared Non-contact Thermometer, Model ACT8100	Easywell Biomedicals, Inc.	FLL	Class II	2017-03-10
K160815	Interstitial Needles	Varian Medical Systems, Inc.	JAQ	Class II	2017-03-10
K170528	Sterispine™ PS	Safe Orthopaedics	NKB	Class II	2017-03-09
K170391	ANSiStim-PP	Dyansys, Inc.	BWK	Unclassified	2017-03-09
K170267	BGM009 Plus Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2017-03-09
K170126	NuVasive® Reline® 4.5-5.0 System	Nu Vasive, Incorporated	NKB	Class II	2017-03-09
K170124	Level One Hand Plating System	KLS-Martin L.P.	HRS	Class II	2017-03-09