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 2026-11-02, 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 1035 of 3531

510(k) clearances, page 1035 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091188	Asahi Zenyteex Guiding Catheter	Asahi Intecc Co., Ltd.	DQY	Class II	2010-02-26
K083876	Sfi-Bar System Complete 2-Implant and 4-Implant	Cendres & Metaux SA	NHA	Class II	2010-02-26
K100125	Vision Sciences Flexible ENT Scope	Cogentix Medical, Inc.	EOB	Class II	2010-02-25
K093942	Ensite Velocity System V1.3	Abbott Medical	DQK	Class II	2010-02-25
K093741	Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (Hp) Mic Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2010-02-25
K093592	Advocate Redi-Cod Duo Blood Glucose Plus Blood Pressure Monitoring System, Model Td-3223	Taidoc Technology Corporation	NBW	Class II	2010-02-25
K093015	Binder Intervertebral Body Fusion Device	Binder Biomedical, Inc.	MAX	Class II	2010-02-25
K091006	Itg Vascular Access System, Model 300	Arstasis, Inc.	DYB	Class II	2010-02-25
K100267	Fleximarc, Model Cm-0.9-2-10-Gg-L	Cortex Manufacturing, LLC	IYE	Class II	2010-02-24
K100228	Versapulse Model P20 Laser System	Lumenis Ltd	GEX	Class II	2010-02-24
K093751	Cl-Dc20, Cl-Dc21	Good Doctors Co., Ltd.	EBZ	Class II	2010-02-24
K093748	Dd Bio Z and Dd Bio Z - Transpa	Dental Direkt of Amerika UG (Haftungsbeschraenkt)	EIH	Class II	2010-02-24
K093647	Traxcess Docking Wire	Terumo Cardiovascular Systems Corporation	DQX	Class II	2010-02-24
K093475	Basesens Blood Glucose Monitoring System	Hygeia, Ltd.	NBW	Class II	2010-02-24
K093425	Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha	Mako Surgical Corp.	OLO	Class II	2010-02-24
K093409	Powerpump Arthroscopy System	Medical Vision AB	HRX	Class II	2010-02-24
K093181	Gyrus Acmi Pk Button Electrode	Gyrus ACMI, Inc.	FAS	Class II	2010-02-24
K093026	Footprint Medical 1.9 Fr Picc Introducer	Footprint Medical Inc.	DYB	Class II	2010-02-24
K092894	Easymax V Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	NBW	Class II	2010-02-24
K092369	12Sl ECG Analysis Program	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2010-02-24
K091880	Clayton Intra-Aural Device (Cid)	Ascentia Health Incorporated	MQC	Unclassified	2010-02-24
K091766	Clearview Exact Pbp2a Test, Model 891-000	Binax, Inc.	MYI	Class II	2010-02-24
K091612	Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;	Ucp Biosciences, Inc.	DJG	Class II	2010-02-24
K091298	Lubrease Female Lubricant	Curves Limited	NUC	Class II	2010-02-24
K090068	Steritite Universal Container System and Meditray Products	Case Medical, Inc.	FRG	Class II	2010-02-24
K100227	Sas Flualert A&b, Sas Influenza a Test	SA Scientific, Ltd	PSZ	Class II	2010-02-23
K100107	Smith & Nephew Sureshot Distal Targeting System V2.0	Smith & Nephew, Inc.	OLO	Class II	2010-02-23
K100092	Corvus Radiation Therapy Planning System	Best Nomos	MUJ	Class II	2010-02-23
K093798	Powder Free Vinyl Patient Examination Glove	Supermax Plastic Products Co., Ltd.	LYZ	Class I	2010-02-23
K093797	Powder Free Vinyl Patient Examination Gloves (Yellow, White)	Supermax Plastic Products Co., Ltd.	LYZ	Class I	2010-02-23
K093653	Uresil Gastrostomy Catheter Kit , Model Gcl-630Hbk	Uresil, LLC	KNT	Class II	2010-02-23
K093621	Syngo.pet&ct Oncology	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2010-02-23
K093086	Arthrosteer Ablator & Coagulator, Models: Ref 1070 & 1080	Orthodynamix, LLC	GEI	Class II	2010-02-23
K092712	Skin Barrier Film	Lodestar Products, Inc.	KMF	Class I	2010-02-23
K092681	Powdered Latex Examination Gloves, Non-Sterile	Khai Hoan Joint Stock Company	LYY	Class I	2010-02-23
K092580	Tidi Facemask	Tidi Products, LLC	FXX	Class II	2010-02-23
K091860	Aeskulisa Mpo, Model 30-7303Us	Aesku Diagnostics	MOB	Class II	2010-02-23
K091496	Mep-90 Hair Growth Stimulation System	Midwest Rf, LLC	OAP	Class II	2010-02-23
K100380	Altera Nebulizer System, Model 678G1002	Pari Respiratory Equipment, Inc.	CAF	Class II	2010-02-22
K093726	Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2010-02-22
K093718	Zutron Medical Endoscope Leak Tester Model Zutr-10003	Zutron Medical	FCY	Class I	2010-02-22
K093426	Bact-Trap Hepa Midi	Pharma Systems AB	CAH	Class II	2010-02-22
K092144	Bonastent Esophageal, Models Be and Ber, Bonastent Esophageal U.e.s. Flange and Flare, Models Befg and Befr	Boston Scientific Corporation	ESW	Class II	2010-02-22
K091806	Pogo Screw Instrumentation Tray	Fxdevices	KCT	Class II	2010-02-22
K091283	Capillarys Neonat Hb (Pn 2006)	Sebia, Inc.	GKA	Class II	2010-02-22
K090019	Natus Neuroworks, Model 104196	Bio-Logic Systems Corp.	OMB	Class II	2010-02-22
K100209	Bd Eclipse Needle with Smartslip Technology	Becton Dickinson & Co	FMI	Class II	2010-02-19
K100204	Sonalis	Smith Associates	ITX	Class II	2010-02-19
K100197	Genesis Unicondylar Uhmwpe Articular Inserts	Smith & Nephew, Inc.	HSX	Class II	2010-02-19
K093805	Oscar 3	Orthosonics, Ltd.	JDX	Class II	2010-02-19