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 919 of 3530

510(k) clearances, page 919 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113663	Sonixtablet Ultrasound Scanner	Ultrasonix Medical Corporation	IYN	Class II	2012-01-25
K113632	Dp-5 Digital Ultrasonic Diagnostic Imaging System Dp-7 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	IYO	Class II	2012-01-25
K112981	Sun 125C Ionization Chamber	Sun Nuclear Corporation	LHN	Class II	2012-01-25
K112576	Endochoice Water Bottle Cap System	Boston Scientific Corporation	FEQ	Class II	2012-01-25
K112312	Theratrode	Phoenix Medical Devices, LLC	GXY	Class II	2012-01-25
K112251	Swissmeda Dental Planning System	Swissmeda AG	LLZ	Class II	2012-01-25
K112206	Cardiff Anterior Cervical Plate System	Seaspine, Inc.	KWQ	Class II	2012-01-25
K111634	Xenon(tm) Pedicle Screw System	Alphatec Spine, Inc.	NKB	Class II	2012-01-25
K111337	Tornier Collagen Coated Biofiber Scaffold	TORNIER Inc.	FTL	Class II	2012-01-25
K113858	Megabeam Endo-ENT Probe	Biolitec Medical Devices, Inc.	GEX	Class II	2012-01-24
K113167	Mtf New Bone Voild Filler	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2012-01-24
K113154	Ivas Balloon Catheter	Stryker Corp.	NDN	Class II	2012-01-24
K113059	Contiplex Fx	B.Braun Medical, Inc.	CAZ	Class II	2012-01-24
K112904	Steritec Containers System & Meditray Products	Case Medical, Inc.	FRG	Class II	2012-01-24
K112858	Genesis Touch System	Honeywell Hommed, LLC	DRG	Class II	2012-01-24
K112705	Audit(r) Microlq(tm) Serum Protein Control	Aalto Scientific Ltd.	JJY	Class I	2012-01-24
K111877	Ezs05 Cleaning and Disinfecting Solution, Bausch + Lomb Ezs05 Cleaning and Disinfecting Solution	Bausch & Lomb Incorporated	LPN	Class II	2012-01-24
K110923	Cobas 4800 CT / Ng Test	Roche Molecular Systems Inc	MKZ	Class I	2012-01-24
K113661	Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls	Lin-Zhi International Inc	LAF	Class II	2012-01-23
K113301	Concenpiece,high-Speed Handpiece Series	Dentalez, Inc.	EFB	Class I	2012-01-23
K113146	Pcxx Varnish	Ross Healthcare, Inc.	LBH	Class II	2012-01-23
K113092	Zimmer Contour Provisional Coping	ZimVie US Corp LLC	NHA	Class II	2012-01-23
K112808	Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites	Omega Laboratories, Inc.	DIO	Class II	2012-01-23
K112574	Prime-Dent Dual Cure Composite Luting Cement	Prime Dental Manufacturing, Inc.	EMA	Class II	2012-01-23
K111971	Synde-Lock Syndesmosis Repair Kit	Tarsus Medical, Inc.	HWC	Class II	2012-01-23
K110534	Randox Liquid Cardiac Control Levels 1, 2 and 3	Randox Laboratories, Limited	JJY	Class I	2012-01-23
K113800	Quill Quadrahelix Tissue-Closure Device	Angiotech	GAW	Class II	2012-01-20
K113769	Gpscath Ballon Dilatation Catheter	Hotspur Technologies	LIT	Class II	2012-01-20
K113709	Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece	Biolitec Medical Devices, Inc.	GEX	Class II	2012-01-20
K113645	Regeneross Allograft Plus Minerlized	Biomet Interpore Cross	NUN	Class II	2012-01-20
K113527	Opticage Interbody Fusion Device	Interventional Spine, Inc.	MAX	Class II	2012-01-20
K113509	Lexus Anterior Cervical Plate System	L&K Biomed Co.,Ltd.	KWQ	Class II	2012-01-20
K113480	Spectra Optia Apheresis System	Terumo BCT, Ltd	LKN	Unclassified	2012-01-20
K113302	Namsa Steam Self-Contained Biological Indicators	North American Science Assoc., Inc.	FRC	Class II	2012-01-20
K113294	Smith & Nephew Healicoil Pk Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2012-01-20
K113132	Disposable Hemostatic Y-Connectors	Coeur, Inc.	DTL	Class II	2012-01-20
K112936	Safe'sound Luer Lock Passive Devlivery System	Rexam Consummer Plastics Inc.D/B/A Rexam Pharma	MEG	Class II	2012-01-20
K112934	Neurotech Recovery	Bio-Medical Research, Ltd.	GXY	Class II	2012-01-20
K112918	Durablue Sterilization (Amsco V-Pro) Wrap	Cardinal Health200, LLC	FRG	Class II	2012-01-20
K112725	Liaison 25 Oh Vitamin D Total Assay	Diasorin Inc.	MRG	Class II	2012-01-20
K112662	Microfrance(r) Wormald Vascular Clamp	Medtronic Xomed, Inc.	DXC	Class II	2012-01-20
K112343	Treponema Pallidum Treponemal Test Reagents; Quality Control Materials	Siemens Healthcare Diagnostics Inc.	LIP	Class II	2012-01-20
K112161	Aqt90 Flex Analyzer, Aqt90 Flex Myoglobin Test Kit, Aqt90 Flex Lqc Multi-Check, Lvls 1-3, Aqt90 Flex Myo Cal Cartridge..	Radiometer Medical ApS	KHO	Class I	2012-01-20
K111202	Surgical Tissue Management System	Olympus Medical Systems Corp.	GEI	Class II	2012-01-20
K110896	Reliance Spinal Screw System	Reliance Medical Systems, LLC	MNI	Class II	2012-01-20
K110874	Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator	Siemens Healthcare Diagnostics Inc.	JZG	Class II	2012-01-20
K110406	Celltracks Autoprep System	Veridex, LLC	NQI	Class II	2012-01-20
K103697	Torqtech	J. Morita USA, Inc.	EGS	Class I	2012-01-20
DEN120008	Stratify Jcv(tm) Antibody	DiaSorin Molecular LLC	OYP	Class II	2012-01-20
K120010	Cable/ Lead-Wire (ECG, EKG, Spo2 and Invasive Blood Pressure)	Shenzhen Med-Link Electronics Tech Co.,Ltd	DSA	Class II	2012-01-19