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 1440 of 3531

510(k) clearances, page 1440 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030719	Pentacam Scheimpflug Camera	Oculus Optikgerate GmbH	MXK	Class II	2003-09-16
K030504	Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060	Idev Technologies, Inc.	MCW	Class II	2003-09-16
K032566	Natural Comfort Battery/electric Breast Pump	The First Years, Inc.	HGX	Class II	2003-09-15
K032518	Pasco Mic and Mic/id Panels, Gemifloxacin (Strep)	Lee Laboratories, Inc.	JWY	Class II	2003-09-15
K032431	Prisma M60/m100 Sets	Gambro, Inc.	KDI	Class II	2003-09-15
K032212	Kyphx Directional Inflatable Bone Tamp, Models K16a and K17a	Medtronic, Inc.	HRX	Class II	2003-09-15
K032054	Radionics Nashold Biopsy Needle - Single Use	Radionics, A Division of Tyco Healthcare Group LP	HAW	Class II	2003-09-15
K031983	Inovo, Inc, Economizer Conserving Regulator	Inovo, Inc.	NFB	Class II	2003-09-15
K031972	Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,	asap endoscopic products GmbH	HRX	Class II	2003-09-15
K031932	Fluoride Varnish	Dentsply Intl.	LBH	Class II	2003-09-15
K031337	Acumen Surgical Navigation System	Zimmer GmbH	HAW	Class II	2003-09-15
K030614	3I Dental Implants	ZimVie US Corp LLC	DZE	Class II	2003-09-15
K024148	Salinum, Orclair	Sinclair Pharmaceuticals Ltd	LFD	Unclassified	2003-09-15
K023837	Lifesign Home Drug Test (Ecstasy/met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma	Princeton BioMeditech Corp.	LAF	Class II	2003-09-15
K032754	Vortex Mp	Boston Scientific Corporation	LJT	Class II	2003-09-12
K032653	E275	Micro Current Technology, Inc.	GZJ	Class II	2003-09-12
K032652	Rs-4I Muscle Stimulator Family	RS Medical	IPF	Class II	2003-09-12
K032618	3.0T 8 Channel Neurovascular (Nv) Array Coil	GE Healthcare Coils	MOS	Class II	2003-09-12
K032588	Modification to Fixion Intramedullary Nailing System (Fixion Im)	Disco-O-Tech Medical Technologies, Ltd.	HSB	Class II	2003-09-12
K032552	Accu-Chek Advantage System	Roche Diagnostics GmbH	NBW	Class II	2003-09-12
K032541	Polestar N-20	Medtronic Navigation, Inc	LNH	Class II	2003-09-12
K032538	3.0T 8-Channel Cervical-Thoracic-Lumbar (Ctl) Array Coil	GE Healthcare Coils	MOS	Class II	2003-09-12
K032393	Induction and Sampling Manifold (or Stopcock)	Elcam Medical A.C.A.L.	FMG	Class II	2003-09-12
K032229	Quantum Warp 10 Light Delivery System	Quantum Devices, Inc.	ILY	Class II	2003-09-12
K032163	Duracon Total Knee System	Howmedica Osteonics Corp	MBH	Class II	2003-09-12
K032150	Safety-Multifly	Sarstedt ApS	FPA	Class II	2003-09-12
K032033	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2003-09-12
K031359	S-Monovette Edta K2-Gel	Sarstedt ApS	PJE	Class II	2003-09-12
K030961	Microlife Digital Basal Thermometer, Model Mt 1921	Microlife Corp.	LHD	Unclassified	2003-09-12
K030564	Thermoskin Conductive Pads	united pacific Company	GXY	Class II	2003-09-12
K030522	Aosept Clear Care Cleaning and Disinfecting Solution	Alcon Laboratories	LPN	Class II	2003-09-12
K030466	Handydop	Elcat, GmbH	KNG	Class II	2003-09-12
K032658	Microlife Model Mt18e1-1 (V932-1) Digital Underarm Electronic Thermometer	Microlife Intellectual Property GmbH	FLL	Class II	2003-09-11
K032640	Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System	U-Systems, Inc.	IYO	Class II	2003-09-11
K032638	Dome Cx Digital Flat-Panel Display System Model, C3 Color and C3 Gray	Planar Systems, Inc.	LLZ	Class II	2003-09-11
K032561	Resume II Lead Kit for Spinal Cord Stimulation (Scs) and Peripheral Nerve Stimulation (Pns), Resume Tl Lead Kit for	Medtronic, Inc.	GZB	Class II	2003-09-11
K032418	Duracon Total Knee System with Peri-Apatite Coating	Howmedica Osteonics Corp	MBH	Class II	2003-09-11
K032153	Bd Phoenix Automated Microbiology System Cefotaxime 0.5-64 Ug/ml	Lee Laboratories, Inc.	LON	Class II	2003-09-11
K031985	Spinal Concepts Inc. Nex-Link Spinal Fixation System	Spinal Concepts, Inc.	MNI	Class II	2003-09-11
K031951	Transdiscal System (Transdiscal Probe), Model Tdp-17-150-6	Baylis Medical Co., Inc.	GEI	Class II	2003-09-11
K031899	Quickvue Influenza A+b Test	Ortho-Clinical Diagnostics, Inc.	PSZ	Class II	2003-09-11
K031801	Pantos, Models: Pantos 16, and Pantos Dg	Blue X Imaging SRL	MUH	Class II	2003-09-11
K031721	Composite Restoration Material	Milton Hodosh, M.D.	EBF	Class II	2003-09-11
K022258	B.t.i. Biotechnology Institute, S.l. Dental Implant System	B.T.I. Biotechnology Institute, S.L.	DZE	Class II	2003-09-11
K022156	Latex Ultrasonic Probe Cover	Pleasure Latex Products Sdn. Bhd.	ITX	Class II	2003-09-11
K032624	Micrus Microcatheter	Micrus Corp.	DQO	Class II	2003-09-10
K032548	Ip-Xs Compression Nail System	Plus Orthopedics	HSB	Class II	2003-09-10
K032535	Modification To:roche Diagnostics Tina-Quant Rheumatoid Factors II Test System	Roche Diagnostics GmbH	DHR	Class II	2003-09-10
K032404	Seldinger Safety Needle Introducer	Hdc Corp.	DYB	Class II	2003-09-10
K032399	Vitek 2 Gram Positive Moxifloxacin	bioMerieux, Inc.	LON	Class II	2003-09-10