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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3385 of 3526

510(k) clearances, page 3385 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791995	Anti Nuclear Antibody Test	Meda Stat Diagnostics, Inc.	DHN	Class II	1979-10-30
K791988	Repl. Piston for Troutman Corneal Punch	Edward Weck, Inc.	HNJ	Class I	1979-10-30
K791953	Pdc 304 Double Swab Culture Collection	Precision Dynamics Corporation	JTW	Class I	1979-10-30
K791946	Of Basal Medium	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-30
K791945	Nitrate Broth	Isle Media and Sterile Products, Inc.	JSF	Class I	1979-10-30
K791944	Nitrate Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-30
K791943	Nutrient Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-10-30
K791942	Bile Esculin Azide Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-10-30
K791941	Phenol Red Broth	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-30
K791940	Urea Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-10-30
K791939	Phenol Red Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-30
K791936	Atmos ENT Cabinet Practica 2	JEDMED Instrument Company	ETF	Class I	1979-10-30
K791935	Atmos ENT Cabinet Practica 3	JEDMED Instrument Company	ETF	Class I	1979-10-30
K791934	Atmos ENT Treatment System Servant 3	JEDMED Instrument Company	ETF	Class I	1979-10-30
K791917	X-Pak	Contemporary Surgical Systems, Inc.	HMX	Class I	1979-10-30
K791903	Coulter Diff3 Sys. (Coulter #7400003)	Coulter Electronics, Inc.	GKZ	Class II	1979-10-30
K791898	Ocutome Model 8000	Cooper Medical Devices Corp.	HKP	Class II	1979-10-30
K791893	19091-Xxxxx Ser. of Glass Capillary Col.	Hewlett-Packard Co.	DII	Class I	1979-10-30
K791884	Rionet Hearing Aid Hi-60	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-10-30
K791882	Rionet Hearing Aid Hb-67T	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-10-30
K791877	Rionet Hearing Aid Hb-32H	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-10-30
K791876	Rionet Hearing Aid Hb-32	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-10-30
K791837	Vma by Column Test	Bio-Rad	CDF	Class I	1979-10-30
K791823	3M Upf Proximal Femur Replacement System	3M Company	KWY	Class II	1979-10-30
K791745	Model H44-80 Behind the Ear Hearing	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-10-30
K791684	Warm-Ee Heat Pack	U.S. Export Marketing Group, Inc.	IME	Class I	1979-10-30
K791521	Veri-Vu Lensometer	Intermedics, Inc.	HLM	Class I	1979-10-30
K791172	Oreia-Tu Thyroid Uptaker Ratio Assay	Organon LLC			1979-10-30
K792105	Critikon Dual Channel Recorder	Critikon Company, LLC	DSF	Class I	1979-10-26
K792099	50Mm Writer Model Cvm 9529	C-V Monitors Corp.	DSF	Class I	1979-10-26
K792088	Aortic Occluder #000390	Edward Weck, Inc.	DWS	Class I	1979-10-26
K792035	Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire	Bivona Medical Technologies	BTR	Class II	1979-10-26
K792028	Ototome Bur	American Sterilizer Co.	EQJ	Class I	1979-10-26
K792022	Herbert Bone Screw	Zimmer GmbH	HWC	Class II	1979-10-26
K792021	Large Volume 5 Micron Conical Filter	National Patent Development Corp.	FPB	Class II	1979-10-26
K792016	Discard-a-Pad 40-Count Sharps Disposal	Arbrook Mfg. Corp.	MMK	Class II	1979-10-26
K792012	Skil-Care Super-Soft Limb Restraints	Skil-Care Corp.	FMQ	Class I	1979-10-26
K792010	Tc02m Electrode Adhesive Rings	Novametrix Medical Systems, Inc.	KLK	Class II	1979-10-26
K792009	Tc02 M Oxygen Electrode Contact	Novametrix Medical Systems, Inc.	KLK	Class II	1979-10-26
K792001	Comficare Pad (for Singel Pt Use)	Hamilton Industries, Inc.	FNM	Class II	1979-10-26
K791998	60Cc Irrigating Syringe, Piston Type,	Waz Industries, Inc.	KYZ	Class I	1979-10-26
K791993	Skil-Care Bed Rail Pads	Skil-Care Corp.	FNJ	Class I	1979-10-26
K791992	Dynacor Sterile Carelon Silicone Cath.	MEDLINE INDUSTRIES, LP - Northfield	KOD	Class II	1979-10-26
K791930	IV Extension Set Sl	Abbott Medical	FPA	Class II	1979-10-26
K791925	Den-Mat 4-Minute Denture Cleaner	Den-Mat Corp.	JER	Class I	1979-10-26
K791921	Cardiac Pacemaker C4000, C1000 Ser.	Vitatron Medical BV	DXY	Class III	1979-10-26
K791886	i.v. Care Kit	Ascep, Inc.	KGX	Class I	1979-10-26
K791879	Rionet Hearing Aid Hb-64S	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-10-26
K791858	Cardioplegia Admin. Sets	Travenol Laboratories, S.A.	DWF	Class II	1979-10-26
K791830	L/u Arm - Neuro - Vascular #B5080b	General Electric Co.	JAA	Class II	1979-10-26