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 924 of 3530

510(k) clearances, page 924 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112657	Aureflo Monitoring System	Transonic Systems Inc	DPW	Class II	2011-12-21
K112521	Fukuda Denshi Vasera Model Vs-1500	Fukuda Denshi USA, Inc.	DXN	Class II	2011-12-21
K112506	Xpress Multi-Sinus Dilation Tool	Entellus Medical, Inc.	LRC	Class I	2011-12-21
K112437	Arthrex Fracture System	Arthrex GmbH	HTN	Class II	2011-12-21
K112317	Fm-9000 Plus Fetal and Maternal Monitor	Advanced Instrumentations, Inc.	HGM	Class II	2011-12-21
K112302	Proclear Toric Xr, Proclear Multifocal Xr, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses	CooperVision, Inc.	LPL	Class II	2011-12-21
K112274	U-Right Td-3135 Blood Pressure Monitoring System	Taidoc Technology Corporation	DXN	Class II	2011-12-21
K111446	Sovereign Compact Phacoemulsification System	Advanced Medical Optics, Inc.	HQC	Class II	2011-12-21
K111303	Dermatological Treatment Device Family	Sharplight Technologies Ltd.	GEX	Class II	2011-12-21
K111055	Galaxy System; Jupiter	Personal Health Institute International	OLV	Class II	2011-12-21
K110794	Amecath Cvc and Amecath Pressure Cvc Short Term Single and Multi-Lumen Catherization Kits	Ameco Medical Industries	FOZ	Class II	2011-12-21
K113598	Power-Load Cot Fastener System	Stryker Medical	FPO	Class II	2011-12-20
K113534	Healix Knotless Anchor	DePuy Mitek, Inc.	MAI	Class II	2011-12-20
K113528	Clydesdale(r) Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2011-12-20
K113523	Limacorporate Smr Reverse Shoulder System	Lima Corporate S.p.A.	PHX	Class II	2011-12-20
K113468	Elm Pta Ballon Dilatation Catheter	Creagh Medical Ltd.	LIT	Class II	2011-12-20
K113399	Ifs Subtalar Implant	Internal Fixation Systems, Inc.	HWC	Class II	2011-12-20
K113136	21.3Inch (54Cm)color Lcd Monitor Ccl256i2(cl21256)	Totoku Electric Co., Ltd.	LLZ	Class II	2011-12-20
K113043	Direct Antibiotic Infusion Kit	Summit Medical Products, Inc.	LJS	Class II	2011-12-20
K113028	Medisiss Reprocessed Arthroscopic Shavers and Burs	Medisiss	HRX	Class II	2011-12-20
K113004	Pds(tm) Barbed Sutures	Ethicon, Inc	NEW	Class II	2011-12-20
K112941	Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components	Smith & Nephew, Inc.	JWH	Class II	2011-12-20
K112430	I-Stat Lactate Test/i-Sat Cg4+cartridge	Abbott Pont of Care, Inc.	KHP	Class I	2011-12-20
K112102	Michele Sleep Scoring Systems	Younes Sleep Technologies	MNR	Class II	2011-12-20
K103554	Metron-Cp/md	Eponatech, LLC	LLZ	Class II	2011-12-20
K103508	Unmiax Laparoscopic Instrument	Unimax Medical Systems Inc.	GEI	Class II	2011-12-20
K103022	Kim	Neomedic International S.L.	OTN	Class II	2011-12-20
K102921	Endoscopic Monopolar Instruments and Accessories	Bema-GmbH & Co. KG	GEI	Class II	2011-12-20
K102499	Duofertility	Cambridge Temperature Concepts, Ltd.	LHD	Unclassified	2011-12-20
K101926	Fora D40 Blood Glucose Plus Blood Pressure Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-12-20
DEN100013	Vioguard Self-Sanitizing Keyboard, Model Uvkb50	Vioguard	OSZ	Class II	2011-12-20
K113434	Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)	Lanx, Inc.	NKB	Class II	2011-12-19
K112990	Acl Tightrope,acl Tightrope Duuble Bundle	Arthrex GmbH	HTY	Class II	2011-12-19
K112926	Axsos Locking Plate System	Stryker Corp.	HRS	Class II	2011-12-19
K112885	Zimmer Plates and Screws System Screws Only	Zimmer GmbH	HWC	Class II	2011-12-19
K112862	Mecta-C	Medacta International SA	ODP	Class II	2011-12-19
K112704	Lipiflow Thermal Pulsation System	TearScience, Inc.	ORZ	Class II	2011-12-19
K112587	Advanced Perfusion System 1 (Aps1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,	Terumo Cardiovascular Systems Corporation	DWB	Class II	2011-12-19
K112443	Architect Active B-12 (Holotranscobalamin)	Axis-Shield Diagnostics, Ltd.	CDD	Class II	2011-12-19
K112056	Echelon 60 Endoscopic Linear Cutter Reload, Black Model Ecr60t, Echelon 45 Endoscopic Linear Cutter Reload, Black Model	Ethicon Endo-Surgery Inc	GDW	Class II	2011-12-19
K111831	Mx-7000 Microxel	Bio-Med USA, Inc.	ONG	Class II	2011-12-19
K111013	Acem	Diversatek Healthcare Inc	FFZ	Class II	2011-12-19
K110895	Ortho Solutions Trauma Implants for Osteosynthesis	Ortho Solutions Inc	HWC	Class II	2011-12-19
K102908	Nofact IX	R2 Diagnostics, Inc.	GJT	Class II	2011-12-19
K102851	Nofact VIII	R2 Diagnostics, Inc.	GJT	Class II	2011-12-19
K113448	Biograph Mct Family	Siemens Medical Solutions USA, Inc.	KPS	Class II	2011-12-17
K113226	8Mp Color Lcd Monitor,radiforce Rx840	Eizo Nanao Corporation	LLZ	Class II	2011-12-17
K112997	Hd-Ivus Ultrasound Imaging System	Silicon Vally Medical Instruments, Inc.	IYN	Class II	2011-12-17
K113647	Dc-8/Dc-8 Pro/dc-8 Cv/dc-8 Exp/dc-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2011-12-16
K113543	Ondemand3d	Cybermed Inc.	LLZ	Class II	2011-12-16