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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3064 of 3528

510(k) clearances, page 3064 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841878	Sheath Remover	Datascope Corp.	LJS	Class II	1984-07-13
K841876	Polyurethane Thermal Dilution Cathet	Waters Instruments, Inc.	DYG	Class II	1984-07-13
K841867	Kidd Vaginal Speculum	Paul H. Schneider Ent.	HIB	Class II	1984-07-13
K841828	Central Venous Catheter W/big-Gard	Norton Performance Plastics Corp.	DQY	Class II	1984-07-13
K841705	Wedge Pressure Catheter Flow Directed	Mansfield Scientific, Inc.	DYG	Class II	1984-07-13
K841491	Conventional Plastic Dental Trays	Buffalo Dental Mfg Co Inc	EHY	Class I	1984-07-13
K840762	Silvertorque Cerebral Catheter	Surgimed Corp.	DQY	Class II	1984-07-13
K840742	Right Atrial Catheter	The Healthcare Group Laboratories, Inc.	LJS	Class II	1984-07-13
K840593	Disposa-Spec	Plasti-Products, Inc.	ERA	Class I	1984-07-13
K842221	Wako Glucose C	Wako Pure Chemical Industries, Ltd.	CGA	Class II	1984-07-12
K842110	Slide Pregnancy Test	Immunostics, Inc.	JHJ	Class II	1984-07-12
K842087	Bisfil-I Light Curable Posterior Compo	Bisco, Inc.	EBF	Class II	1984-07-12
K842078	Johnson & Johnson Flavored Etching Gel	Johnson & Johnson Professionals, Inc.	KLE	Class II	1984-07-12
K841826	Natura-Dent Vacuum-Fired Porcelain Teeth	Parexel Intl. Corp.	ELL	Class II	1984-07-12
K841790	Lifescan EEG Monitor	Neurometrics	OLT	Class II	1984-07-12
K841511	Haematuria Catheters	Warne Surgical Products, Ltd.	KOD	Class II	1984-07-12
K840885	Lakeville Body Ventilator	Edwards Ventilator Co.	BYT	Class II	1984-07-12
K840840	Generated Retinal Reflex Imagery Sys	Electro Optical Instruments	HKM	Class I	1984-07-12
K842600	Strep-a-Chek	E-Y Laboratories, Inc.	JSF	Class I	1984-07-11
K842558	Sheridan/intensa Tube	Sheridan Catheter Corp.	BTR	Class II	1984-07-11
K842523	Bird Heated Humidifier 3201	3M Company	BTT	Class II	1984-07-11
K842484	Leap Le Test Kit	Cooper Biomedical, Inc.	LKJ	Class II	1984-07-11
K842196	Stratus Primidone Florometric Enzy	American Dade	LFT	Class II	1984-07-11
K842071	Fiax Transferrin Test Kit	Intl. Diagnostic Technology	DDI	Class II	1984-07-11
K842042	Il 1312, Ph Blood Gas Manager	Instrumentation Laboratory Co.			1984-07-11
K842026	H-Type Bridge Remover	Higa Manufacturing, Ltd.	EIS	Class I	1984-07-11
K841983	Cook Pacemaker 216 Bipolar Cardiac -	Cook Pacemaker Corp.	DXY	Class III	1984-07-11
K841928	Cook Pacemaker 215 Unipolar Cardiac-	Cook Pacemaker Corp.	DXY	Class III	1984-07-11
K841864	Quantimetric Tm 2 Kappa & Lambda Kit	Kallestad Laboratories, Inc.	DEH	Class II	1984-07-11
K841858	Spiroloop	Datamed, Inc.	BSE	Class II	1984-07-11
K841733	Ohio Waste Gas Scavenging Reservoir	Ohio Medical Products	CBN	Class II	1984-07-11
K841623	Slotted Soft-Tissue Instrument	Plastafil, Inc.	HWQ	Class I	1984-07-11
K841622	Soft-Tissue Instrument	Plastafil, Inc.	HWQ	Class I	1984-07-11
K841619	Drill Guide	Plastafil, Inc.	FZX	Class I	1984-07-11
K841415	Beta Stick, Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1984-07-11
K834479	Reliable	Reliable Hearing Aide	LRB	Class I	1984-07-11
K842685	Becton Dickinson 1000 Insulin Pump	BD Becton Dickinson Vacutainer Systems Preanalytic			1984-07-10
K842167	Tbg Ria	Syncor Intl. Corp.	CEE	Class II	1984-07-09
K842161	Ventrezyme Phenytoin Kit Immunoassay	Ventrex Laboratories, Inc.	DIP	Class II	1984-07-09
K842029	Triglycerides-Gpo Reagent	Reagents Applications, Inc.	CDT	Class I	1984-07-09
K841891	Varian 3300 & 3400 Gas Chromatographs	Varian Assoc., Inc.	KZQ	Class I	1984-07-09
K841791	Plume Fistula Needle	Hospal Medical Corp.	FIQ	Class II	1984-07-09
K841544	Amer. Pharmaseal Siliconized Latex	American Pharmaseal Div. Ahsc	KOD	Class II	1984-07-09
K841428	Jejunostomy Set for Tube Feeding	Burron Medical Products, Inc.	KNT	Class II	1984-07-09
K841258	Foreign Body Protector	Jayco Pharmaceuticals	FED	Class II	1984-07-09
K841234	Halo Co Laser System	Directed Energy, Inc.	GEX	Class II	1984-07-09
K841197	Cysto-Aid	E-Z-EM, Inc	KNX	Class II	1984-07-09
K841173	Ostomy Freedom Kit	Ellenberg Assoc.	EXB	Class I	1984-07-09
K832327	Sila Clean 20/20	Professional Supplies, Inc.			1984-07-09
K842492	Amer. Medical Plastics Co 20100	American Medical Plastics Co.	CAI	Class I	1984-07-06