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 1584 of 3531

510(k) clearances, page 1584 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012157	Churchill Medical Systems Stopcock	Vygon Mfg	FMG	Class II	2001-09-11
K011926	Elec-Mate E	Nakanishi Inc.	EBW	Class I	2001-09-11
K011848	Circon Aeh-4 Electrohydraulic Lithotripsy Probe	Circon Video	FFK	Class II	2001-09-11
K011407	Latex Powder-Free Examination Gloves Blue, Polymer Coated, Contains 50 Micrograms or Less of Total Water Extractable Pro	Sempermed USA, Inc.	LYY	Class I	2001-09-11
K011403	Surgiplaster Calcium Sulfate Hemihydrate	Orthogen Corp.	LYC	Class II	2001-09-11
K011242	Huanqiu and Super (Two Brands) Sterile Acupuncture Needle for Single Use	Acusupply, Inc.	MQX	Class II	2001-09-11
K011066	Sterile Latex Surgical Gloves (Powdered) with Protein Content Labeling Claim (100 Micrograms or Less)	Smart Glove Corp. Sdn Bhd	KGO	Class I	2001-09-11
K011045	Textured Powder-Free Latex Examination Gloves Contains 50 Micrograms or Less of Total Water Extractable Protein per Gram	Shen Wei (USA), Inc.	LYY	Class I	2001-09-11
K010973	Diascreen 50 Urine Chemistry Analyzer, Model # 1242-00; Diascreen Reagent Strip for Urinalysis, Cat. # D11000	Arkray Factory USA, Inc.	JIL	Class II	2001-09-11
K010303	Artscan Cartilage Stiffness Testing Device	Artscan Medical Innovations	NGR	Class II	2001-09-11
K012902	Poly per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly per-Q-Cath Dual Lumen Picc Catheter, Model 3246100	C.R. Bard Inc	LJS	Class II	2001-09-10
K012704	Clearfil St Opaquer	Kuraray Medical, Inc.	EBF	Class II	2001-09-10
K012703	Clearfil Core New Bond	Kuraray Medical, Inc.	EBF	Class II	2001-09-10
K012442	Modification to Clearfil Se Bond	Kuraray Medical, Inc.	KLE	Class II	2001-09-10
K012229	Scale-Tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, Model N661wc	National Custom Ent., Inc.	FMT	Class II	2001-09-10
K012223	Cg-2211 Selfcheck ECG Transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	2001-09-10
K012136	Avita Agil It 101 Instant Digital Thermometer	Avita Corporation	FLL	Class II	2001-09-10
K011888	Pressure Activated Check Valve	Vygon Mfg	FPA	Class II	2001-09-10
K011841	Ksea Sawahle Electromechanical Morcellator	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	2001-09-10
K011044	Textured Powder-Free Latex Examination Gloves with Contains 50 Micrograms or Less of Total Water Extractable Protein per	Shen Wei (USA), Inc.	LYY	Class I	2001-09-10
K010618	Palomar Dermalux Pulsed Light System	Palomar	GEX	Class II	2001-09-10
K000031	Aquanet, Model Ec 2000	Prime Pacific Health Innovations Corporation	KPL	Class II	2001-09-10
K012836	Modification to: Lightspeed Plus Mobile CT System	GE Healthcare	JAK	Class II	2001-09-07
K012590	Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System	Cordis US Corp.	FGE	Class II	2001-09-07
K012208	Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895	Siemens Healthcare Diagnostics Inc.	DDC	Class II	2001-09-07
K011836	Mpf Acetabular Cup	Plus Orthopedics	LZO	Class II	2001-09-07
K011828	Cynosure Acclaim Dermatology Laser	Cynosure, LLC	GEX	Class II	2001-09-07
K011816	Mini Multileaf Collimator, Model Kmi	Mrc Systems GmbH	IXI	Class II	2001-09-07
K011810	Orthogenesis Lps Proximal Tibial Replacement and Orthogenesis Lps Tibial Bearing	Depuy, Inc.	KRO	Class II	2001-09-07
K011806	Protege Self-Expanding Nitinol Stent with Starport Delivery Technology	Sulzer Intratherapeutics, Inc.	FGE	Class II	2001-09-07
K011664	Imager II Angiographic Catheter	Boston Scientific/Medi-Tech	DQO	Class II	2001-09-07
K010750	Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560	Fisher Diagnostics	GGN	Class II	2001-09-07
K012656	Liquichek Cardiac Markers Control Lt Level 1,2,3, Models 646,647,648	Bio-Rad	JJT	Class I	2001-09-06
K012584	Modification to: Bd Durasafe Plus Epidural Lock Cse Needle Set/kit	BD	CAZ	Class II	2001-09-06
K012568	Ge Vision Nuclear Medicine Workstation	General Electric Co.	KPS	Class II	2001-09-06
K012564	Modification to: Vectorvision Frameless Biopsy System	Brainlab, Inc.	HAW	Class II	2001-09-06
K012539	Verastep	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	2001-09-06
K012441	Panavia F	Kuraray Medical, Inc.	EMA	Class II	2001-09-06
K012360	Lc Temporary Filling	Parkell, Inc.	EBG	Class II	2001-09-06
K012332	Jas Carbon Dioxide Liquid Reagent	JAS Diagnostics/Drew Scientific	KHS	Class II	2001-09-06
K012055	3.25Mm Spline Twist Implant	Sulzer Dental, Inc.	DZE	Class II	2001-09-06
K012050	Viatrac 14 Plus Peripheral Dilatation Catheter	Boston Scientific Corporation	DQY	Class II	2001-09-06
K011908	Optibond Solo Plus 3	Kerr Dental Materials Center	EBC	Class II	2001-09-06
K011875	Modification to the Tac' Pin	New Deal, S.A.	JDW	Class II	2001-09-06
K011823	Biorehab System	Nicolet Biomedical, Inc.	HCC	Class II	2001-09-06
K011821	Modification to the I.c.o.s Screw	New Deal, S.A.	HWC	Class II	2001-09-06
K011818	Sterile EMG Electrodes	Nicolet Biomedical, Inc.	IKT	Class II	2001-09-06
K011815	Synthes Lcp Proximal Humerus Plates	Synthes (USA) Products LLC	KTW	Class II	2001-09-06
K011387	Neurotherm, Model Jk4	Eurolink, LLC	GXI	Class II	2001-09-06
K011361	Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable	Catheffects, LLC	DRF	Class II	2001-09-06