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 789 of 3530

510(k) clearances, page 789 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140033	Target3d Fusion	Convergent Life Sciences, Inc.	LLZ	Class II	2014-02-27
K133854	Arthrex Ibalance Tka System	Arthrex GmbH	JWH	Class II	2014-02-27
K133773	Sensititre 18-24 Hour Mic Suceptibility System	Thermo Fisher Scientific Oy	JWY	Class II	2014-02-27
K133647	Emv3.1 Pro Blood Glucose System and Emv3.1 Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	NBW	Class II	2014-02-27
K133115	Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack	Advanced Medical Optics, Inc.	HQC	Class II	2014-02-27
K132957	Madsen Accuscreen Type 1077	Natus Medical Denmark ApS	GWJ	Class II	2014-02-27
K132811	Sarns Soft-Flow Extended Aortic Cannula	Terumo Cardiovascular Systems Corporation	DWF	Class II	2014-02-27
K132553	U&u Sterile Piston Syringe without Needle	U&u Medical Technology Co., Ltd	FMF	Class II	2014-02-27
K131876	M Series Patient Monitor	Mid-Link Consulting Co, Ltd.	MHX	Class II	2014-02-27
K140282	St Sense Nv 8 Array Coil	Resonance Innovations, LLC	MOS	Class II	2014-02-26
K140254	Ezono 4000	Ezono AG	IYN	Class II	2014-02-26
K140034	Surefire Guiding Catheter	Surefire Medical, Inc.	DQY	Class II	2014-02-26
K133536	Emerge Medical Bone Plate System	Emerge Medical	HRS	Class II	2014-02-26
K133517	Nemus 2 System	EB Neuro S.p.A.	GWL	Class II	2014-02-26
K133385	Lungpoint Atv Planning and Navigation Software	Broncus Medical Inc	LLZ	Class II	2014-02-26
K133018	Osi Q System Arthroscopes	Orthopedic Sciences, Inc	HRX	Class II	2014-02-26
K132889	Fletcher Ct/mr Shielded Applicator Set (6 Mm) Fletcher Ct/mr Shielded Applicator Set (4 Mm)	Nucletron BV	JAQ	Class II	2014-02-26
K132496	Arthrosurface Toemotion	Arthrosurface, Inc.	LZJ	Unclassified	2014-02-26
K131791	Ifa 40: Hep-20-10	Euroimmun US Inc.	DHN	Class II	2014-02-26
K131770	Pressure Connecting Tube	Shenzhen Ant Hi-Tech Industrial Co., Ltd.	DQO	Class II	2014-02-26
K131626	Exceleron Bacterial Filters	Exceleron Medical, LLC	CAH	Class II	2014-02-26
K131598	Anal Rectal Overtube	United States Endoscopy Group, Inc.	FED	Class II	2014-02-26
K130650	Status Ds Oxy	Princeton BioMeditech Corp.	DJG	Class II	2014-02-26
K123508	Trinias	Shimadzu Corp.	OWB	Class II	2014-02-26
K123162	U&u Hydrogen Peroxide Gas Plasma Sterilization Pouch/roll	U&u Medical Technology Co., Ltd	FRG	Class II	2014-02-26
K140118	Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue Cartridge	Cardica, Inc.	GDW	Class II	2014-02-25
K134020	Intonemv	Incontrol Medical, LLC	KPI	Class II	2014-02-25
K133968	Wondfo Multi-Drug Urine Test Cup, Panel	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2014-02-25
K133904	Cd Horizon Spinal System Growth Rod Set	Medtronic Sofamor Danek USA Inc	PGM	Class II	2014-02-25
K133696	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	NHA	Class II	2014-02-25
K133644	Syngo.via Mi Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-02-25
K133501	Leadliner Cs Lead Delivery System	Vascular Solutions LLC	DQY	Class II	2014-02-25
K133320	Sicat Function	Sicat GmbH & Co. KG	LLZ	Class II	2014-02-25
K133287	Presson Spinal Fixation System	Nexus Spine, L.L.C.	MNH	Class II	2014-02-25
K133177	Modified Hd Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2014-02-25
K133162	Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla	Materialise N.V.	JWH	Class II	2014-02-25
K133137	Cisnap Closed Incision System	Spiracur, Inc.	OKO	Class II	2014-02-25
K133059	Insulin Pen Needle	Wenzhou Beipu Science & Technology Co., Ltd.	FMI	Class II	2014-02-25
K133058	Insulin Pen Needle	Wenzhou Wuzhou Import & Export Co., Ltd.	FMI	Class II	2014-02-25
K132814	Sfi-Bar Implant Abutments	Sterngold Dental LLC	NHA	Class II	2014-02-25
K132690	Up600 Diagnostic Doppler Ultrasound System	Qisda Corporation	IYN	Class II	2014-02-25
K132599	Smilebond System	Millennium Company, LLC	ELW	Class II	2014-02-25
K132389	Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked	Daniel & Daniel Consulting	OWN	Class II	2014-02-25
K132344	E-Z Check Ozone Test Strips	Reprocessing Products Corporation (RPC)	MSY	Class II	2014-02-25
K131503	Se-601 Series Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2014-02-25
K130580	Retraction Paste	Dmg USA, Inc.	MVL	Unclassified	2014-02-25
K130517	Ez Transport Chair	Harris Medical, LLC	IOR	Class I	2014-02-25
K133691	Extrimilock Ankle Plating System	Osteomed	HRS	Class II	2014-02-24
K133625	Agility 10 Standard & Soft 0.01In. X 195Cm, Agility 14 Standard & Soft 0.014In X 205Cm & Xl 350Cm, Agility 16 Standard &	Cerenovus, Inc.	MOF	Class II	2014-02-24
K133615	Well Lead PVC Hydrophilic Urethral Catheter	Well Lead Medical Co. Ltd	EZD	Class II	2014-02-24