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 820 of 3530

510(k) clearances, page 820 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131221	Larval Debridement Therapy Products - Biobag 50/100/200/300/400	Biomonde	NQK	Unclassified	2013-08-28
K131170	Sonicision Sterilization Tray	Covidien, Formerly Valleylab, A Division of Tyco H	KCT	Class II	2013-08-28
K131155	Ugft3; Fht7	Medisim Ltd.	FLL	Class II	2013-08-28
K131124	Colign	Jilin Coronado Medical, Ltd.	DTL	Class II	2013-08-28
K131061	Restore Bunion Correction System	Medartis AG	JDR	Class II	2013-08-28
K131048	Lidco Cnap Module	Lidco Ltd	DXG	Class II	2013-08-28
K130716	Bioretec Activascrew Interference	Bioretec Ltd.	MAI	Class II	2013-08-28
K130461	Stalif X	Centinel Spine, LLC	OVD	Class II	2013-08-28
K123999	Illumask Acne Light Therapy Mask	La Lumiere, LLC	OLP	Class II	2013-08-28
K123724	Dermiseb Cream	Igi Laboratories, Inc.	FRO	Unclassified	2013-08-28
K122197	Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies	Phadia AB	DHB	Class II	2013-08-28
K121925	Powdered Latex Surgeon's Glove	Suzhou Colour-Way Enterprise Development Co., Ltd.	KGO	Class I	2013-08-28
K132360	Kendall Scd 700 Sequential Compression Controller	Medtronic, Inc.	JOW	Class II	2013-08-27
K131376	Smartcoat 2.5% Naf Varnish	Elevate Oral Care, LLC	LBH	Class II	2013-08-27
K131198	Tipi OTC	Contipi, Ltd.	HHW	Class II	2013-08-27
K131197	Edgewise Ceramic Brackets, Roth Ceramic Brackets	Dental Morelli	NJM	Class II	2013-08-27
K131068	Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid	Kuraray Noritake Dental, Inc.	EJK	Class II	2013-08-27
K131049	Zrp	Apex Dental Materials, Inc.	KLE	Class II	2013-08-27
K130462	Paltop Narrow Implant, Paltop Short Implant	Paltop Advanced Dental Solutions Ltd	DZE	Class II	2013-08-27
K123987	Improve Blood Collection Set and Improsafe Blood Collection Set	Innovative Medical Technologies, Inc	JKA	Class II	2013-08-27
K123797	Nt1d Vital Signs Monitor	New Tech, Inc.	DQA	Class II	2013-08-27
K132238	Proparaflu+ Assay	Gen-Probe Prodesse, Inc.	OOU	Class II	2013-08-26
K132237	Prodesse Profast+ Assay	Gen-Probe Prodesse, Inc.	OQW	Class II	2013-08-26
K131949	Aem Disposable Suction Irrigation Electrodes	Encision, Inc.	GEI	Class II	2013-08-26
K131527	Logiq S8	GE Healthcare	IYN	Class II	2013-08-26
K131212	Premier Ceramic Primer	Premier Dental Products Co	KLE	Class II	2013-08-26
K131101	Itero Software	Cadent, Ltd. an Align Technology Company	NHA	Class II	2013-08-26
K131082	Interform Interbody Cage System	Next Orthosurgical	MAX	Class II	2013-08-26
K130635	Seviin Surface Replacement Shoulder	Ingen Orthopedics, LLC	HSD	Class II	2013-08-26
K130130	Atg/sm-Osa Appliances	Selane Products, Inc.	LQZ	Class II	2013-08-26
K123436	First Response Early Result Pregnancy Test	Church & Dwight Co., Inc.	LCX	Class II	2013-08-26
K132535	Autoband Ligator	Boston Scientific Corporation	MND	Class II	2013-08-23
K132268	Quill Pdo Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corporation dba Angiotech	NEW	Class II	2013-08-23
K132054	Gynecare Tvt Exact Continence System	Ethicon, Inc	OTN	Class II	2013-08-23
K131978	Selectra Accessory Kit, Selectra Slitter Tool	BIOTRONIK AG	DQY	Class II	2013-08-23
K131878	Lliad, Kora, Zenius Pedicle Screw System	Medyssey USA	NKB	Class II	2013-08-23
K131374	Tempus(tm) Cervical Plate System	Neurostructures, Inc.	KWQ	Class II	2013-08-23
K131012	Sutter Bipolar Forceps - Supergliss	Sutter Medizintechnik GmbH	GEI	Class II	2013-08-23
K130798	Pre-Formed Guidewires	Lake Region Medical	DQX	Class II	2013-08-23
K130516	Cardioday	Getemed Medizin- und Informationstechnik AG	DQK	Class II	2013-08-23
K130403	Magstim Double 70-2 Coil	Magstim Inc.	GWF	Class II	2013-08-23
K130268	Bd Probetec Trichomonas Vaginalis (Tv) Qx Amplified DNA Assay	Becton Dickinson & Co	OUY	Class II	2013-08-23
K130244	Diatrue Plus Blood Glucose Monitoring System	Delbio Incorporation	NBW	Class II	2013-08-23
K130137	Biosonic Suvi Piezeoelectric Scaler and Polisher	Coltene /Whaledent AG	ELC	Class II	2013-08-23
K124010	Accusonic Advantage	Metron Medical Australia, Pty, Ltd.	IMI	Class II	2013-08-23
K122355	Vanishpoint Blood Collection Set	Retractable Technologies, Inc.	JKA	Class II	2013-08-23
K132352	Sas Flualert a & B, Sas Influenza a Test	SA Scientific, Ltd	GNX	Class I	2013-08-22
K132332	Mountaineer Oct Spinal System	Medos International SARL	KWP	Class II	2013-08-22
K132204	Insuflow Synergy Xl Port	Lexion Medical, LLC.	HIF	Class II	2013-08-22
K132169	Surgiquest Airseal Ifs	Surgiquest, Inc.	GCJ	Class II	2013-08-22