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 900 of 3530

510(k) clearances, page 900 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121132	Ezsensor P Digital Intraoral Sensor	Humanray Co,Ltd	MQB	Class II	2012-05-10
K120537	Aquamantys3 9.5 Xl Bipolar Sealer	Medtronic, Inc.	GEI	Class II	2012-05-10
K120521	Gc Blue Silicone	GC America Inc.	ELW	Class II	2012-05-10
K120369	Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)	Canon Medical Diagnostics USA, Inc.	CFR	Class II	2012-05-10
K120327	Vertessa	Caldera Medical, Inc.	OTO	Class II	2012-05-10
K113813	Sentrysuite Product Line	Carefusion Germany 234 GmbH	BTY	Class II	2012-05-10
K113177	Complete D 25-Oh Vitamin D Control	Quantimetrix Corp.	JJX	Class I	2012-05-10
K112952	Ilwait Timer Oculopressor	Oryx Medical Pty, Ltd.	LCC	Class II	2012-05-10
K112896	Arrw Evolution	Arrow International (Subsidiary of Teleflex Inc.)	LJS	Class II	2012-05-10
K112856	Lucina-Melodi	Genadyne Biotechnologies, Inc.	HGX	Class II	2012-05-10
K112794	Eos Small Bone Fixation System	Trimed Inc	HRS	Class II	2012-05-10
K112660	Pocketcpr	ZOLL Medical Corporation	LIX	Class II	2012-05-10
K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads	Lima Corporate S.p.A.	LPH	Class II	2012-05-10
K121084	Loci Cardiac Troponin-I Control (Low), Lctni Con L	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2012-05-09
K120491	Dss Stabilization System-Rigid	Paradigm Spine GmbH	MNH	Class II	2012-05-09
K120353	Synster Pedicle Screw System Synster Plus Pedicle Screw System	BM Korea Co., Ltd.	MNH	Class II	2012-05-09
K121209	Terumo Pall Al20x Arterial Filter	Terumo Cardiovascular Systems Corporation	DTM	Class II	2012-05-08
K121166	Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel	Guangzhou Wondfo Biotech Co., Ltd.	DIO	Class II	2012-05-08
K121116	Plateau Spacer System	Life Spine	MAX	Class II	2012-05-08
K121072	Somatom Definition Flash	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-05-08
K120860	Infu Box Type 0412A	Medical Rescue Equipment Holding AS	LGZ	Class II	2012-05-08
K120761	Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls	Lin-Zhi International Inc	DJG	Class II	2012-05-08
K120717	Synthes Variable Angle Lcp Elbow System (Medical and Posterolateral Distal Humerus Plates)	Synthes (USA) Products LLC	HRS	Class II	2012-05-08
K120693	Latex Examination Gloves (Powdered)	Top Calibre Sdn Bhd	LYY	Class I	2012-05-08
K120637	Synapse 3D Brain Perfusion	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2012-05-08
K120513	Glow by Endymed	Endymed Medical Inc.	OUH	Class II	2012-05-08
K120396	Reliance Cervical Ibf System	Reliance Medical Systems, LLC	ODP	Class II	2012-05-08
K120394	Lifestyles Zero Lubricated Latex Condom	Ansell Heathcare Products, LLC	HIS	Class II	2012-05-08
K120298	Cps Excel Mediguide Enabled Guidewire	St. Jude Medical, Cardiac Rhythm Management Divisi	DQX	Class II	2012-05-08
K120149	Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 Sg Steam Sterilizer Sakura Steam Sterilizer Assv-Ab09 Sakura	Sakura Seiki Co., Ltd.	FLE	Class II	2012-05-08
K120072	Venous Drainage Cannula with Duraflo Coating	Edwards Lifesciences LLC	DWF	Class II	2012-05-08
K120026	Performer Ht/ Hang&go Ht Basic	Rand S.r.l.	LGZ	Class II	2012-05-08
K113853	G+ System	Glytec, LLC	NDC	Class II	2012-05-08
K113751	Randox Cocaine Metabolite	Randox Laboratories, Limited	DIO	Class II	2012-05-08
K113670	Element Blood Glucose Monitoring System	Infopia Co, Ltd.	CGA	Class II	2012-05-08
K113639	C2 Medical Gloves	Amercare, Inc.	LZA	Class I	2012-05-08
K113577	Merits Model R Series Positioning System for Powered Wheelchair	Merits Health Products, Inc.	ITI	Class II	2012-05-08
K113521	Calcium Gen. 2	Roche Diagnostics GmbH	CHW	Class II	2012-05-08
K113451	Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software Na Vis-Ex	Nidek Technologies SRL	HKI	Class II	2012-05-08
K112403	Amsco Chimeron Medium Steam Sterlilzer	STERIS Corporation	FLE	Class II	2012-05-08
K112378	Cobes Surgical Drape	Cobes Industries Co., Ltd.	KKX	Class II	2012-05-08
K112334	Vein-Gogh Instrument	Refine USA, LLC	ONQ	Class II	2012-05-08
K112266	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Zhiyuan Medical Products Co., Ltd.	LYZ	Class I	2012-05-08
K110420	Ophira Mini Sling System	Promedon	PAH	Class II	2012-05-08
K102841	Pantex Am/pm Salivary Cortisol Enzyme Immunoassay	Pantex, Div. Bio-Analysis, Inc.	NHG	Class II	2012-05-08
K120724	Pioneer Lateral Plate System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2012-05-07
K120550	Carto(r) Ep Navigation System, Version 3.0 (with Standard Location Pad)	Biosense Webster Inc	DQK	Class II	2012-05-07
K120106	Apixia Digirex Digital Dental Rediography System	Apixia Inc.	MUH	Class II	2012-05-07
K113732	Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan ENT, Iplan Cmf, Iplan View, Iplan Spine)	Brainlab, Inc.	JAK	Class II	2012-05-07
K113713	Gen_2 Mechanical Wheelchair	Free Wheelchair Mission	IOR	Class I	2012-05-07