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 2355 of 3531

510(k) clearances, page 2355 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921311	Cordis Shuttle Catheter W/ Sideholes	Cordis US Corp.	DQY	Class II	1992-09-09
K915859	Myotrac/s, Myodac/s	Thought Technology Ltd.	HCC	Class II	1992-09-09
K915858	Myotrac2	Thought Technology Ltd.	HCC	Class II	1992-09-09
K915329	Patient Examination Gloves (Maycare)	Malaysian Healthcare Sdn. Bhd	LYY	Class I	1992-09-09
K922295	Omega Plus Compress Hip Screw System, Modification	Howmedica Corp.	KTT	Class II	1992-09-08
K922048	Duracon All Plastic Tibial Component	Howmedica Corp.	JWH	Class II	1992-09-08
K921640	Kinemax Plus All Plastic Tibial Component	Howmedica Corp.	JWH	Class II	1992-09-08
K924225	Oxygen Swivel Adapter (Plastic)	Linjorel Products, Inc.	BZA	Class I	1992-09-04
K922752	Starkey Laboratories Otoscope	Starkey Laboratories, Inc.	ERA	Class I	1992-09-04
K922677	Magnetization Transfer Contrast	Resonex, Inc.	LNH	Class II	1992-09-04
K922495	Super Gloves(r) Hypoallergenic	Taiping Super Holdings Sdn Bhd	LYY	Class I	1992-09-04
K922364	Dua-900A Image-Intensified Fluoroscopic X-Ray Syst	Toshiba America Medical Systems, In.C	IXR	Class II	1992-09-04
K921415	Irrigation Tubing Set	Psi Medical Products, Inc.	KOD	Class II	1992-09-04
K921200	Guidewire	Lake Region Mfg., Inc.	KNY	Class II	1992-09-04
K920830	New Freedom Ultra Thin Pads	Kimberly-Clark Corporation	HHD	Class I	1992-09-04
K920777	Laborie Urodynamics Processor	R. Laborie Surgical, Ltd.	FAP	Class II	1992-09-04
K920627	Model Eli 100 Electrocardiograph	Mortara Instrument, Inc.	LOS		1992-09-04
K920626	Model Eli 200 Electrocardiograph	Mortara Instrument, Inc.	LOS		1992-09-04
K920619	Tri-Med Gastric Lavage System	Tri-Med Specialties, Inc.	KDH	Class II	1992-09-04
K920527	Tri-Med Quick-Step Gastric Lavage Kit	Tri-Med Specialties, Inc.	KDH	Class II	1992-09-04
K920439	Omega Oto Nasopharyngo-Laryngoscope	Omega Universal Technologies, Ltd.	EOB	Class II	1992-09-04
K914260	4240 Dynamic Bp/heart Rate Monitor	Suntech Medical Instruments, Inc.	DXN	Class II	1992-09-04
K912486	Singh Speech System (Series 'Sss')	Exmoor Plastics Limited	EWL	Class II	1992-09-04
K902515	Acuson S228 Transducer for Transcranial Color Dopp	Acuson Corp.	ITX	Class II	1992-09-04
K922620	Amk Fixed Stem Cemented Tibial Tray	Depuy, Inc.	JWH	Class II	1992-09-03
K921491	Medi-Stim	Mid-Canada Medical	LIH	Class II	1992-09-03
K920743	Dual Lead (Ecg1 & Ecg2) Arrhythmia Analysis	Nihon Kohden America Inc	DSI	Class II	1992-09-03
K915737	Autotransfusion Blood Collection Reservoir	Electromedics, Inc.	DTN	Class II	1992-09-03
K915296	Monopolar Electrode	Lifeguard Medical Products, Inc.	GEI	Class II	1992-09-03
K914122	Vital Infusion Pump	Vital Resources Corp.	FRN	Class II	1992-09-03
K923167	The Nissel Artificial Eye	Nissel, Ltd.	HQH	Class I	1992-09-02
K923015	Total T3 Chemiluminescence Assay	Nichols Institute Diagnostics	CDP	Class II	1992-09-02
K922963	Tl100w/12	Philips Lighting Co.	FTC	Class II	1992-09-02
K922878	Model Gt1st Cryosurgical Instrument	Gyne-Tech Instrument Corp.	GEH	Class II	1992-09-02
K922820	Woodbine Xt350, Xenon Arc Light Source	Woodbine Ptical Corp.	FST	Class II	1992-09-02
K922749	Low Profile Tracheostomy Tube	Concord/Portex	BTO	Class II	1992-09-02
K922585	Bartels Toxoplasma Igg Eia	Baxter Diagnostics, Inc.	LGD	Class II	1992-09-02
K922579	Bartels Toxoplasma Igm Eia	Baxter Diagnostics, Inc.	LGD	Class II	1992-09-02
K922578	Bartels Lyme Disease Igm Eia	Baxter Diagnostics, Inc.	LSR	Class II	1992-09-02
K922526	Davol Laparoscopic Loop and Retrieval Devices	Davol, Inc.	GCJ	Class II	1992-09-02
K922489	Medpor Surg Implant Material:prefor Cran/fac Impla	Porex Technologies Corp.	FWP	Class II	1992-09-02
K922335	Bartels Rubeola Igm Eia	Baxter Diagnostics, Inc.	LJB	Class I	1992-09-02
K922332	Bartels Epstein-Barr Virus Igg Eia	Baxter Diagnostics, Inc.	LSE	Class I	1992-09-02
K922331	Bartels Epstein-Barr Virus Igm Eia	Baxter Diagnostics, Inc.	LJN	Class I	1992-09-02
K922330	Bartels Rubeola Igg Eia	Baxter Diagnostics, Inc.	LJB	Class I	1992-09-02
K922279	Illuminator IV Minor Surgery Light	Medical Illumination, Inc.	FSW	Class II	1992-09-02
K922258	Spectacle Frames	British Optical Import Co.	HQZ	Class I	1992-09-02
K922246	Tubing Set W/ Irrigation & Aspiration Valving	Everest Medical Corp.	GCJ	Class II	1992-09-02
K922170	Amerlite Prolactin-30 Assay	Eastman Kodak Company	CFT	Class I	1992-09-02
K922081	Labotech Automated Microtiter Analyzer	Innovative Medical Systems, Inc.	JJQ	Class I	1992-09-02