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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1725 of 3533

510(k) clearances, page 1725 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991066	Madtronic Dlp Arterial Cannulae	Medtronic, Inc.	DWF	Class II	1999-09-14
K991036	Danek Plate and Screw System	Sofamor Danek USA,Inc.	MNH	Class II	1999-09-14
K990212	Lockjaw 15 Minute Intermaxillary Fixation System,model Lj100-00	Doctor'S Research Group, Inc.	DYX	Class II	1999-09-14
K983276	Hydrofera Bacteristatic Nasal Dressing	Hydrofera, LLC.	EMX	Class I	1999-09-14
K982910	Hamilton Medical Galileoventilator	Hamilton Medical AG	CBK	Class II	1999-09-14
K972267	Helica Tc	Tenerco, Inc.	GEI	Class II	1999-09-14
K992803	Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1Oop	Sigma Diagnostics, Inc.	CHH	Class I	1999-09-13
K992743	Collins Cpl	Collins Medical, Inc.	BZG	Class II	1999-09-13
K992419	Royal Shield Non-Sterile Blue Colored Powdered Latex Examination Glove with Protein Content Labeling Claim (200 Mcgm or	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1999-09-13
K992418	Royal Shield Non-Sterile Pink Colored Powdered Latex Examination Glove with and without Strawberry Scent and with Protei	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1999-09-13
K992417	Royal Shield Non-Sterile Powdered Latex Examination Gloves (Protein Labeling Claim) 200 Mcgm or Less of Total Water Extr	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1999-09-13
K992312	K-Assay Crp (2), K-Assay Crp Multi-Calibrator a, K-Assay Crp Multi-Calibrator B	Kamiya Biomedical Company, LLC	DCK	Class II	1999-09-13
K992311	K-Assay Crp(1), K-Assay Crp Multi-Calibrator a, K-Assay Crp Multi-Calibratorc	Kamiya Biomedical Company, LLC	DCK	Class II	1999-09-13
K992308	Oocyte Retrieval Needle Set, Model 90138	Lifetek Medical, Inc.	MQE	Class II	1999-09-13
K992307	Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo Transfer Catheter	Fertility Technology Resources, Inc.	MQF	Class II	1999-09-13
K992194	Cortical Mapping Unit, Model Cmu	AD-Tech Medical Instrument Corp.	GYC	Class II	1999-09-13
K992131	Samsung Raypax Long Term Archive	Samsung Sds Co., Ltd.	LMB	Class I	1999-09-13
K992119	Bio-Modular Shoulder System	Zimmer GmbH	KWS	Class II	1999-09-13
K992057	Ist Response Manual Resuscitator, Models, 008000, 008003,008006	Abbott Medical	BTM	Class II	1999-09-13
K991799	Davol Hysteroscopy Pouch Drape and Tubing Set, Model Ooxxxxo	Davol Inc., Sub. C.R. Bard, Inc.	HIG	Class II	1999-09-13
K991388	Assisted Hatching Micropipettes, Denuding Pipettes, Holding Micropipettes, Icsi Micropipettes, Partial Zone Dissection M	Pacific Andrology, Inc.	MQH	Class II	1999-09-13
K991218	Oratec Bipolar Ablation Probes	Oratec Interventions, Inc.	GEI	Class II	1999-09-13
K973971	Kion Anesthesia System	Siemens Medical Solutions USA, Inc.	BSZ	Class II	1999-09-13
K972708	Endo-Spor Plus / Hyprocide	Cottrell, Ltd.	MED	Class II	1999-09-13
K992721	Cosman Robert Wells Functional Probe Microdrive	Radionics, Inc.	HAW	Class II	1999-09-10
K992694	Modification to K6-I Diagnostic System, Model K6-I	Myotronics-Noromed, Inc.	KZM	Class II	1999-09-10
K992693	Rita Model 90 Electrosurgical Accessory, Model 90	Boston Scientific Corporation	GEI	Class II	1999-09-10
K992630	Thermalight 2000	Jennifermaxx, Inc.	GEX	Class II	1999-09-10
K992588	Blue Nitrile Patient Examination Gloves, Powder-Free	Formosa Glove Industrial Co., Ltd.	LZA	Class I	1999-09-10
K992358	Correct Touch Powder Free 911 Latex Examination Gloves, (Blue)	Biopro (M) Sdn Bhd	LYY	Class I	1999-09-10
K992345	Christoudias Slim Tip Electrode Insert	Innervision, Inc.	GEI	Class II	1999-09-10
K992210	Shieldmaster Powdered Purple Nitrile Examination Gloves	Safeskin Corp.	LZA	Class I	1999-09-10
K992196	Biologic-Dt System (Biologic-Dt-1000 with Dt-1000-Tk)	Hemocleanse, Inc.	FLD	Class II	1999-09-10
K992015	Freedom Infusion System	Novacon Corp.	MEB	Class II	1999-09-10
K992011	Synea-Hs High Speed-Handpiece	A-dec, Inc.	EFB	Class I	1999-09-10
K991994	Twilight	Biolase MG LLC	GEX	Class II	1999-09-10
K991991	Dupel Iontophoresis System	Empi	EGJ	Class II	1999-09-10
K991990	Tri-Polar System	Zimmer GmbH	KWY	Class II	1999-09-10
K991375	Bard Balloon Inflation System	C.R. Bard Inc	KNT	Class II	1999-09-10
K992864	Render-Plan 3-D	Precision Therapy Intl., Inc.	MUJ	Class II	1999-09-09
K992802	Terumo U-100 Insulin Syringe	Terumo Medical Corp.	FMF	Class II	1999-09-09
K992237	Medtronic Gt2 Fusion Guide Wires	Medtronic, Inc.	DQX	Class II	1999-09-09
K992112	Samsung Raypax Film Digitizer	Samsung Sds Co., Ltd.	LLZ	Class II	1999-09-09
K992091	Punctur-Guard Revolution Holder, Model 4750	Bio-Plexus, Inc.	FMI	Class II	1999-09-09
K992073	Ax Workstation	Siemens Medical Solutions USA, Inc.	LLZ	Class II	1999-09-09
K992038	Pocketspacer	Ferraris Medical, Inc.	CAF	Class II	1999-09-09
K992027	Koninckx Uterine Manipulator, Keckstein-Schiff Uterine Manipulator, Clermont Uterine Manipulator	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1999-09-09
K991986	Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling System Option	LivaNova USA, Inc.	CAC	Class II	1999-09-09
K991969	Health-Plus, Sanitex, Reliance, Pre-Powdered Latex Examination Gloves with Protein Labeling Claim (137 Mcg or Less)	Pamitex Industries Sdn Bhd	LYY	Class I	1999-09-09
K991834	Cholestech Ldx Alanine Aminotransferase (Alt), Model 11-772	Cholestech Corp.	CKD	Class I	1999-09-09