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 2026-10-29, 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 875 of 3530

510(k) clearances, page 875 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121458	Speedicath Compact Set (12/18 Fr)	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2012-10-01
K121425	Ortholoc 3Di Ankle Fusion Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2012-10-01
K120998	Solstice Cross Connector	Life Spine	KWP	Class II	2012-10-01
K120891	Tangors Multifunctional Posterior System	Ulrich GmbH & Co. KG	NKB	Class II	2012-10-01
K120460	Smartlux	medmix Co.,Ltd	GEX	Class II	2012-10-01
K120116	Serf Ablation System Serf Ablation Needle	Thermedical	GEI	Class II	2012-10-01
K113678	Invia Motion Negative Pressure Wound Therapy System	Medela AG	OMP	Class II	2012-10-01
K122825	Acuson	Siemens Medical Solutions USA, Inc.	IYN	Class II	2012-09-28
K122641	Mpact Extension	Medacta International SA	LZO	Class II	2012-09-28
K122451	Exactrac Vero	Brainlab, Inc.	IYE	Class II	2012-09-28
K122433	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2012-09-28
K122270	Overtube Endoscopic Access System	Apollo Endosurgery, Inc.	FED	Class II	2012-09-28
K122263	14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use	Symmetry Medical	ODY	Class II	2012-09-28
K122232	Gmk Narrow	Medacta International SA	JWH	Class II	2012-09-28
K122072	Wallflextm Biliary Rx Stent System (Uncovered, Partially Covered, and Fully Covered) Wallflextm Biliary Transhepatic Ste	Boston Scientific Corporation	FGE	Class II	2012-09-28
K121915	Bright Restorative Materials	Dmp, Ltd.	EBF	Class II	2012-09-28
K121806	Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software	Medtronic, Inc.	DQA	Class II	2012-09-28
K121761	Somnoguard Sp Soft	Tomed Dr. Toussaint GmbH	LRK	Class II	2012-09-28
K121462	Ez-Blocker	Ez-Blocker B.V.	CBI	Class II	2012-09-28
K121286	Epic 10	Biolase MG LLC	GEX	Class II	2012-09-28
K120982	Digital Eye-Fundus Camera	Medimaging Integrated Solutions, Inc. (Miis)	HKI	Class II	2012-09-28
K120289	Peerscope System	Peermedical	FDF	Class II	2012-09-28
K113852	Bausch & Lomb IOL Injector	Bausch & Lomb Incorporated	MSS	Class I	2012-09-28
K112628	Nipro Blood Tubing Set with Transducer Protector and Priming Set	Nipro Medical Corporation	FJK	Class II	2012-09-28
K122266	Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shandong Junfeng Industries Co., Ltd.	LYZ	Class I	2012-09-27
K122096	Karl Storz Navigationpanel Unit (Npu) System	Karl Storz Endoscopy-America, Inc.	HAW	Class II	2012-09-27
K122067	Type 1077 Accuscreen	Natus Medical Denmark ApS	GWJ	Class II	2012-09-27
K122033	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2012-09-27
K121971	Withings, Smart Body Scale	Zhongshan Transtek Electronics Co., Ltd	MNW	Class II	2012-09-27
K121713	Pmt Bone Screws	Providence Medical Technology, Inc.	HWC	Class II	2012-09-27
K121504	Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets	Togo Medikit Co., Ltd.	DYB	Class II	2012-09-27
K120635	Easyone Pro Respiratory Testing Device	Ndd Medizitechnik AG	BTY	Class II	2012-09-27
K120306	Rapicide Opa-28	Medivators Inc	MED	Class II	2012-09-27
K113843	Freedom Nd: Yag Laser System	Lutronic Corporation	PDZ	Class II	2012-09-27
K122623	Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000 (Right); 6 Hole Medium Midshaft	Advanced Orthopaedic Solutions, Inc.	HRS	Class II	2012-09-26
K122611	Coolrail Linear Pen Model Mcri	AtriCure, Inc.	OCL	Class II	2012-09-26
K122507	Durablue Sterilization Wrap, Model Numbers Ch100, Ch200, Ch300, Ch400, Ch500 and Ch600, Sterrad Nx Sterilization	Cardinal Health200, LLC	FRG	Class II	2012-09-26
K122341	Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37	Hitachi Aloka Medical, Ltd.	IYN	Class II	2012-09-26
K122022	Atheroedge	Atheropoint, LLC	LLZ	Class II	2012-09-26
K121567	Oracle Lumbar Intervertebral Body Fusion Cage System	Accel Spine	MAX	Class II	2012-09-26
K121144	Electronic Stethoscope	Sharp Corporation	DQD	Class II	2012-09-26
K120136	Embryogen	CooperSurgical, Inc.	MQL	Class II	2012-09-26
K120087	Exspiron	Respiratory Motion, Inc.	BZK	Class II	2012-09-26
K113483	Iterative Reconstruction Technique Software Application	Philips Healthcare (Cleveland)	JAK	Class II	2012-09-26
K111391	Sterrad (R) 100Nx Duo Cycle Test Pack	Advanced Sterilization Products	FRC	Class II	2012-09-26
K122638	Toshiba 3T 32Ch Head Speeder Coil,	Quality Electrodynamics	MOS	Class II	2012-09-25
K122428	Faxitron Specien Radiography System	Faxitron Bioptics, LLC	MWP	Class II	2012-09-25
K122374	Arthrex Suture (Uhmwpe)	Arthrex GmbH	GAT	Class II	2012-09-25
K121880	Dmrc Nanoflow Dmrc Nanocomposite Ebond Sure Etch Gel Sure Etch Liquid	Danville Materials, Inc.	EBF	Class II	2012-09-25
K121755	Custom Craniofacial Implant (Cci)	Kelyniam Global, Inc.	GXN	Class II	2012-09-25