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 891 of 3530

510(k) clearances, page 891 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113767	Mounted Medical Oxygen System	Essex Industries, Inc	BYJ	Class II	2012-06-29
K113582	Archstent Biliary System	Verge Medical Inc.	FGE	Class II	2012-06-29
K113512	Biomet Microfixation Mandibular Fracture/ Reconstruction Devices and Prebent Plates System	Biomet Microfixation	JEY	Class II	2012-06-29
K113459	Anteplegia Catheter Antegrade Cardioplegia Catheter Aortic Root Cannula Antegrade Catheter with Duraflo Coating	Edwards Lifesciences LLC	DWF	Class II	2012-06-29
K113200	Vitek 2 Ast-Gn Piperacillin/tazobactam	bioMerieux, Inc.	LON	Class II	2012-06-29
K113080	Tubalgator	Mectra Labs, Inc.	HIN	Class II	2012-06-29
K112318	Clearpath 24	Promedic, Inc.	OCX	Class II	2012-06-29
K111949	Ac Wound Treatment System	Nanovibronix, Ltd.	OMP	Class II	2012-06-29
K111785	Freedom(r) Stemmed Tibial Components	Maxx Orthopedics Inc.	JWH	Class II	2012-06-29
K121527	Wi-Fi Body Scale	Shenzhen Healthcare Electronic Technology Co., Ltd.	MNW	Class II	2012-06-28
K121087	Contour Next Usb Blood Glucose Monitoring System	Medrad, Inc.	NBW	Class II	2012-06-28
K120996	Fluoroperm 30 Paragon Hds Fluoroperm 60 Paragon Hds 100 Fluoroperm 92 Fluoroperm 151 Paragon Thin	Paragon Vision Sciences, Inc.	HQD	Class II	2012-06-28
K120918	Nuvasive Coroent Titanium System	NuVasive Inc	MAX	Class II	2012-06-28
K120810	Fiberoptic Laser Delivery System	Fiberoptic Fabrications	GEX	Class II	2012-06-28
K120611	Sony Pvm-2551Md Oled Monitor	Sony Electronics Inc.	GCJ	Class II	2012-06-28
K120375	Med-Rx Patient Delivery Set	Canadian Hospital Specialties Ltd.	FPA	Class II	2012-06-28
K113704	Architect Havab-G	Abbott Medical	LOL	Class II	2012-06-28
K103467	Cmos Video Rhino-Laryngoscope System Model 11101Cm	Karl Storz Endoscopy-America, Inc.	EOB	Class II	2012-06-28
K121522	Polyfit Absorbing Antimicrobial Dressings (OTC)	Polyremedy, Inc.	FRO	Unclassified	2012-06-27
K121295	Artistetm Solution with Sys Vcio	Siemens Medical Solutions USA, Inc.	IYE	Class II	2012-06-27
K121274	Pixel App	Gauss Surgical, Inc.	LWH	Class I	2012-06-27
K121211	Vu Apod Intervertebral Body Fusion Device	Theken Companies LLC	OVD	Class II	2012-06-27
K121049	Unify Dynamic Anterior Cervical Plate System	Globus Medical, Inc.	KWQ	Class II	2012-06-27
K121016	Range Spinal System (Mesa and Denali)	K2M, Inc	MNH	Class II	2012-06-27
K120780	Edward Proplege Peripheral Retrograde Cardioplegia Device	Edwards Lifesciences LLC	DWF	Class II	2012-06-27
K120760	Ldr Spine Spinetune Tl Spinal System	Ldr Spine USA	MNH	Class II	2012-06-27
K120372	Dr Greenburgs Hybrid Vacuum	Always More Marketing Inc	LRK	Class II	2012-06-27
K120371	Dr Greenburgs Hybrid Acrylic	Always More Marketing Inc	LRK	Class II	2012-06-27
K120243	Gam-200	GC America Inc.	EMA	Class II	2012-06-27
K113835	Datacaptor System	Philips North America LLC	MWI	Class II	2012-06-27
K113326	Oral B Plus Outlast Night Time Dental Guard	OraLabs, Inc.	OBR	Unclassified	2012-06-27
K112686	Next Gen EMG Endotracheal Tube	Medtronic Xomed, Inc.	ETN	Class II	2012-06-27
K121681	Glider Ptca Balloon Catheter	Trireme Medical, Inc.	LOX	Class II	2012-06-26
K120680	Enspire Discectomy System	Spine View, Inc.	HRX	Class II	2012-06-26
K120632	Amsco V-Pro 1 Low/plus/max Temperature Sterilization System	STERIS Corporation	MLR	Class II	2012-06-26
K120025	Surgimesh Xb - Skirted	Aspide Medical	FTL	Class II	2012-06-26
K120002	I-Style Bone Marrow Aspiration Needle with T-Handle	Busse Hospital Disposables	KNW	Class II	2012-06-26
K113383	Xtrafix External Fixation System	Extraortho, Inc.	KTT	Class II	2012-06-26
K113017	Sys*stim 240	Mettler Electronics Corp	IPF	Class II	2012-06-26
K111369	The Helena V8 Immunodisplacement Kit	Helena Laboratories UK Ltd	CFF	Class II	2012-06-26
DEN120014	Verigene Gram Positive Blood Culture Nucleic Acid Test (Bc-Gp)	Luminex Corporation	PAM	Class II	2012-06-26
K121290	Aquamantrys3 Bsc 9.1S	Medtronic, Inc.	GEI	Class II	2012-06-25
K120336	Nitrile Powder Free Examination Gloves (Vio) Tested for Use with Chenitrile Powder Free Examination (Ablu) Tested for U	Hartalega Sdn Bhd	LZC	Class I	2012-06-25
K120134	Ips E.max Press Multi	Ivoclar Vivadent, Inc.	EIH	Class II	2012-06-25
K121699	Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2012-06-22
K121646	Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc. Ultrasound Gro	IYN	Class II	2012-06-22
K121577	Aplio Artida Diagnostic Ultrasound System	Toshiba Medical Systems Corporation, Japan	IYN	Class II	2012-06-22
K121532	Hero Graft	Hemosphere, Inc.	DSY	Class II	2012-06-22
K121468	Eurotrol Gas-Ise Metabolites	Eurotrol B.V.	JJY	Class I	2012-06-22
K121459	Syngo.mr Neurology	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2012-06-22