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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1423 of 3531

510(k) clearances, page 1423 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032756	A-Dec 532/533 Delivery System Model, 532/533	A-dec, Inc.	EIA	Class I	2003-12-04
K032659	Depuy Asr Resurfacing Femoral Heads	Depuy Orthopaedics Inc.	KXA	Class II	2003-12-04
K032362	Up-Grade Forehead Thermometer	Medisim Ltd.	FLL	Class II	2003-12-04
K032309	Novelens Contact Lens Cleaning Enhancement and Storage Accessory	Novelens, Inc.	LRX	Class II	2003-12-04
K031733	Non-Contact Tonometer, Model Nt-4000	Nidek, Inc.	HKX	Class II	2003-12-04
K031124	Polaris 95000-a Bedside/transport Monitor	GE Healthcare	MHX	Class II	2003-12-04
K024014	Randox Rx Daytona	Randox Laboratories, Limited	CGA	Class II	2003-12-04
K023023	Lifesite Hemodialysis Access System, Cannula Exchange Kit, Insertion Kit, Access Cannila	Vasca, Inc.	MSD	Class II	2003-12-04
K021692	Clc2000 Catheter Patency Device	Abbott Medical	FPA	Class II	2003-12-04
K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, LLC	KTT	Class II	2003-12-03
K033529	Tie-in Trapezium	Wrightmedicaltechnologyinc	KYI	Class II	2003-12-03
K033516	Depuy Global Cap Ha Resurfacing Shoulder Humeral Heads	Depuy Orthopaedics Inc.	HSD	Class II	2003-12-03
K033510	Modification to Telegraph Humeral Nail	Fournitures Hospitalieres Industrie	HSB	Class II	2003-12-03
K033495	Modification to Equation Fixation System	Medtronic Sofamor Danek	MNI	Class II	2003-12-03
K033202	Advantage Paddle	Livingston Products, Inc.	IZH	Class II	2003-12-03
K033082	9 Second Digital Thermometer, Model Bt-S09	Metatech Corp.	FLL	Class II	2003-12-03
K032988	Elpha 4 Conti	Danmeter A/S	KPI	Class II	2003-12-03
K032752	R&b Surgical Smartplate Cervical Plate System	R&B Surgical Solutions, LLC	KWQ	Class II	2003-12-03
K032735	Spectra Qt: Q-Switched Nd: Yag Laser System	Max Engineering, Ltd.	GEX	Class II	2003-12-03
K032729	Z-Series Modular Total Hip System	Osteoimplant Technology, Inc.	LPH	Class II	2003-12-03
K032626	Permaquick Se Bonding System	Ultradent Products Inc.	KLE	Class II	2003-12-03
K032572	A-Dec/w&h Electric Motor, Model Ea-50Lt	A-dec, Inc.	EBW	Class I	2003-12-03
K031818	Facilai Various Models of Single Use Acupuncture Needle	Facilai Enterprises, Ltd.	MQX	Class II	2003-12-03
K031116	Vectra (Intelect) Epr Ultrasound	Chattanooga Group, Inc.	IMI	Class II	2003-12-03
K030895	Aseptico Endopex V, Model Aeu-40	Aseptico, Inc.	LQY	Unclassified	2003-12-03
K030834	Candela Smoothbeam Laser System	Candela Corporation	GEX	Class II	2003-12-03
K030485	Newmedical Micro Bone Distractor/fixator	Newmedical Technology, Inc.	MQN	Class II	2003-12-03
K024027	Lightwave Infrared Lamps Lw10d and Lw30d	Skytech Enterprises, Inc.	ILY	Class II	2003-12-03
K033553	Pfz Porcelain System	Dentsply Intl.	EIH	Class II	2003-12-02
K033387	Quest Diagnostics Serum Chemistry Control, Models 935 and 945	Bio-Rad	JJY	Class I	2003-12-02
K033246	Preciset Dat Thc and Preciset Dat Thc 20 Calibrators	Roche Diagnostics GmbH	DLJ	Class II	2003-12-02
K033201	La500 Blue Light	Apoza Enterprise Co., Ltd.	EBZ	Class II	2003-12-02
K033138	Cap3 Bone Substitute Material	Etex Corp.	MQV	Class II	2003-12-02
K033100	Taiwan King Strong Powered Wheelchair, Tp 01	Taiwan King Strong Co., Ltd.	ITI	Class II	2003-12-02
K033031	Taiwan King Strong Tc 03 Mechanical Wheelchair	Taiwan King Strong Co., Ltd.	IOR	Class I	2003-12-02
K032968	Trsansderm Ionto System	Mattioli Engineering Corp.	EGJ	Class II	2003-12-02
K032901	Stryker Mini-Mender Meniscal Repair System	Stryker Corp.	GAT	Class II	2003-12-02
K032762	Xio Radiation Treatment Planning System	Elekta Limited	IYE	Class II	2003-12-02
K032645	Justwin Scooter, Js-3014	Joy Ride Tech Co., Ltd.	INI	Class II	2003-12-02
K032643	Justwin Scooter, Js-3013	Joy Ride Tech Co., Ltd.	INI	Class II	2003-12-02
K032488	Wu's 3-Wheeled Neo Scooter, Wt-T3d	Wu's Tech Co., Ltd.	INI	Class II	2003-12-02
K031787	Smith & Nephew Iur Morcellation System	Smith & Nephew, Inc.	HIH	Class II	2003-12-02
K032696	Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument	United States Surgical, A Division of Tyco Healthc	GDW	Class II	2003-12-01
K031671	Polaris Wr	Syneron Medical, Ltd.	GEX	Class II	2003-12-01
K031102	Microlab Spirometer	Micro Direct, Inc.	BZG	Class II	2003-12-01
K023683	Multi-Strap Full Face Mask	Engineered Medical Systems, LLC	BZD	Class II	2003-12-01
K033584	Arthrocare Arthrowands	ArthroCare Corporation	GEI	Class II	2003-11-28
K033509	Modification to Versabond Bone Cement	Smith & Nephew, Inc.	LOD	Class II	2003-11-28
K033499	Malis Irrigation Module 1000	Valley Forge Scientific Corp.	GEI	Class II	2003-11-28
K033452	Cwas 1000	Fasstech	IKN	Class II	2003-11-28