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 1350 of 3531

510(k) clearances, page 1350 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042641	Chemview-10	Cenogenics Corp.	JIL	Class II	2005-01-07
K042330	Acetaminophen-Sl Assay	Sekisui Diagnostics P.E.I. Inc.	LDP	Class II	2005-01-07
K042117	Proxis System, Model Eps 101	Velocimed, Inc.	DQY	Class II	2005-01-07
K041917	Plasiatek Actuator	Plasiatek, LLC	BTR	Class II	2005-01-07
K041824	X-Treme Arthroscopic Pump and Shaver System	Future Medical Systems, Inc.	HRX	Class II	2005-01-07
K040887	B-R-a-H-M-S Pct Lia	Brahms Aktiengesellschaft	NTM	Class II	2005-01-07
K040432	Solar 2 Anatomic Shoulder	Stryker Orthopaedics	HSD	Class II	2005-01-07
K033856	5.0 Cannulated Drill Pin, 6.0 Cannulated Drill-Pin	Peter Stevens, MD	KTT	Class II	2005-01-07
K043535	Hd11 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2005-01-06
K043348	Modification to Pm-8000 Patient Monitor	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MWI	Class II	2005-01-06
K043216	Cadstream Version 4.0	Confirma, Inc.	LLZ	Class II	2005-01-06
K043136	Elity 70 X-Ray	Dental X-Ray E.U.	EHD	Class II	2005-01-06
K042938	Gambro Prismaflex Hf1000 and Hf1400 Sets	Gambro Renal Products	KDI	Class II	2005-01-06
K042868	Mammoreport Softcopy Workstation	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2005-01-06
K042864	Implant Sciences Corp, Model Hdr-4140	Implant Sciences Corp.	KXK	Class II	2005-01-06
K042827	Cardiofax Ce, Model Pea-1110K	Nihon Kohden America Inc	DPS	Class II	2005-01-06
K042814	Readmyheart	Dailycare Biomedical, Inc.	DPS	Class II	2005-01-06
K042483	Invacare Pro, Compact and Portable Desktop	Invacare GmbH	CAF	Class II	2005-01-06
K042479	Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che	Ortho-Clinical Diagnostics, Inc.	LCD	Class II	2005-01-06
K042316	Vanguard Reprocessed Pulse Oximeter Sensors	Stryker Sustainability Solutions	NLF	Class II	2005-01-06
K043552	Vascutek PTFE Supported Eptfe Vascular Prostheses	Vascutek, Ltd.	DSY	Class II	2005-01-05
K043360	Imt.lab	Pie Medical	LLZ	Class II	2005-01-05
K043310	Synthes (USA) Electric Pen Drive System	Synthes (USA) Products LLC	HWE	Class I	2005-01-05
K043295	Versyo.direct	Kulzer GmbH	EBI	Class II	2005-01-05
K043273	Ligasure Vessel Sealing System. Ligasure Instruments	Medtronic, Inc.	GEI	Class II	2005-01-05
K043088	Medtronic Snt Stealthstation Axiem Imageless Knee Module	Medtronic Navigation, Inc	HAW	Class II	2005-01-05
K043146	Horizon Medical Imaging	Change Healthcare Canada Company	LLZ	Class II	2005-01-04
K043127	Haemonetics Cardiovascular Perioperative Autotransfusion System	Haemonetics Corporation	CAC	Class II	2005-01-04
K042432	Pharmguard Toolbox, Model G6000782	Medex, Inc.	FRN	Class II	2005-01-04
K043562	Bc Plus	Vericom Co., Ltd.	KLE	Class II	2005-01-03
K043302	Nova-Pulse	Nova Ranger, Inc.	EBZ	Class II	2005-01-03
K042792	Ixl-II Diabetes Management System	Insulet Corporation	LZG	Class II	2005-01-03
K042678	Rightest Blood Glucose Monitoring System	Bionime Corporation	NBW	Class II	2005-01-03
K042546	Funhaler, Model Fh 101	Infamed, Ltd.	CAF	Class II	2005-01-03
K043230	Vitek Gram Negative Susceptibility (Gns) Card for Ertapenem	bioMerieux, Inc.	LON	Class II	2004-12-30
K042221	Coronis 5Mp Medical Flat Panel Display System	Barco NV Barcoview	LLZ	Class II	2004-12-30
K041125	Masep Srrs Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep Gamma Therapy System)	Masep Med Science & Tech. Development (Shenzhen) C	IWB	Class II	2004-12-30
K033210	Bioteq Double Pigtail Ureteral Stent Set	Bioteque Corp.	FAD	Class II	2004-12-30
K043561	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-12-29
K043481	Modification to: Zilver 635 Biliary Stent	Cook Inc.	FGE	Class II	2004-12-29
K043397	Modification to Bd Eclipse Hypodermic Needle	Becton Dickinson & Co	FMI	Class II	2004-12-29
K043378	Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit	Drew Scientific, Ltd.	JIT	Class II	2004-12-29
K043211	Online Dat Barbiturates Plus	Roche Diagnostics GmbH	DIS	Class II	2004-12-29
K043167	Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195X	Phamatech Inc.	JXM	Class II	2004-12-29
K043162	Pmp4 Oxy Pro	Card Guard Scientific Survival, Ltd.	DQA	Class II	2004-12-29
K043068	Difoti Usb 2.0 System	Electro-Optical Sciences, Inc.	NTK	Class II	2004-12-29
K042975	Ameditech Immutest Multi-Drug Screen Panel II	Ameditech, Inc.	DIS	Class II	2004-12-29
K042916	Watch Pat 100S	Itamar Medical	MNR	Class II	2004-12-29
K042714	Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4	Spine Next America	MQP	Class II	2004-12-29
K042713	Fidji-Vertebral Body Replacement Type 5	Spine Next America	MQP	Class II	2004-12-29