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 2569 of 3530

510(k) clearances, page 2569 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900439	Single-Use, Sterile, Prefilled Syringe, 60Cc	L H M Ent., Inc.	FIH	Class II	1990-02-15
K900417	Wheelchair Lift (Wheelchair Elevator)	Crow River Industries, Inc.	ING	Class II	1990-02-15
K900355	Mark VII Thermoregulation Assist System	Life Enhancement Technologies, LLC	ILO	Class II	1990-02-15
K900330	Quickie P300 Wheelchair	Quickie Designs, Inc.	ITI	Class II	1990-02-15
K900307	Kare Chair I	Kare Chair Industries, Inc.	INO	Class II	1990-02-15
K897192	Triflex Orthopedic Sterile Surgeon's Glove	Baxter Healthcare Corporation	KGO	Class I	1990-02-15
K897179	Orbiter(tm) Treadmill	Lee-Meredith Industries, Inc.	IOL	Class I	1990-02-15
K897045	Bowie-Dick Test Card Catalog Number 008018	Edward Weck, Inc.	JOJ	Class II	1990-02-15
K897034	K-Sponge	Katena Products, Inc.	HOZ	Class II	1990-02-15
K896636	Rmi Anteplegia Cannula	Research Medical, Inc.	DWF	Class II	1990-02-15
K896580	Uni-Polar Head	Richards Medical Co., Inc.	LZY	Class II	1990-02-15
K896579	Goosen Urinary Drainage System	Goosen Enterprises, Inc.	KNX	Class II	1990-02-15
K896549	Storz Fiberoptic Endo-Illuminators	Storz Instrument Co.	HBI	Class II	1990-02-15
K896543	Ultramark 7 Ultrasound System	Advanced Technology Laboratories, Inc.	DXK	Class II	1990-02-15
K896542	Addition to the Continuum Knee System (Cks(tm))	Techmedica, Inc.	JWH	Class II	1990-02-15
K896455	Vitachoice Wound Dressing	Vitaphore Corp.	KGX	Class I	1990-02-15
K896890	Dynasurg Dental Irrigation System	Micro Motors, Inc.	EFS	Class I	1990-02-14
K896693	Flexi-Cast Crown Core System	Essential Dental Systems, Inc.	ELR	Class I	1990-02-14
K896680	Probe Sheath for Adms & Capistrano Labs Transrec.	Interson Corp.	FED	Class II	1990-02-14
K896671	Sarns Membrane Oxygenator W/integral Reser. #9461	3M Company	DTZ	Class II	1990-02-14
K896663	Endo-Prep	Pulpdent Corporation	EKM	Class I	1990-02-14
K896662	Air Block	Pulpdent Corporation	EBF	Class II	1990-02-14
K896661	Ken's Prophy Gel - Regular	Pulpdent Corporation	EJR	Class I	1990-02-14
K896659	Silane	Pulpdent Corporation	KLE	Class II	1990-02-14
K896658	Dentin Disclosing Gel and Gel Remover	Pulpdent Corporation	EBF	Class II	1990-02-14
K896657	Root Canal Sealer, Modified Grossmans' Formula	Pulpdent Corporation	KIF	Class II	1990-02-14
K896656	Root Canal Sealer, Groosmans' Formula Bismuth	Pulpdent Corporation	KIF	Class II	1990-02-14
K896655	9.6% Hydrofluoric Acid Gel	Pulpdent Corporation	KLE	Class II	1990-02-14
K896654	Drying Agent	Pulpdent Corporation	EBF	Class II	1990-02-14
K896653	Separating Medium (Polyvinyl Alcohol)	Pulpdent Corporation	EBF	Class II	1990-02-14
K896602	Fd5000 Dental Chair	Oriola OY Finndent	KLC	Class I	1990-02-14
K895283	Prosthetic Restoration Device	Swiss Precision Mfg. Corp.	EBL	Class I	1990-02-14
K895066	Monogram IV	Leach and Dillon Co., Inc.	EJT	Class II	1990-02-14
K893736	Hot Brush	Home Dental Care, Inc.	JEQ	Class I	1990-02-14
K900561	Glovex Latex Examination Gloves	Medical Latex Corp.	LYY	Class I	1990-02-13
K900479	Sterile Laceration Tray Cat. #749	Busse Hospital Disposables	FSM	Class I	1990-02-13
K900454	Modified Low Powder Single Use Latex Exam Gloves	Phoenix Medical Technology, Inc.	LYY	Class I	1990-02-13
K900453	Modified Single Use Latex Examination Gloves	Phoenix Medical Technology, Inc.	LYY	Class I	1990-02-13
K900383	Bullet Sunglasses	Blublocker LLC	HQY	Class I	1990-02-13
K900382	Blublocker Sunglasses	Blublocker LLC	HQY	Class I	1990-02-13
K900381	Colorvision Sunglasses	Blublocker LLC	HQY	Class I	1990-02-13
K900332	Em 1149 Optimize Scotchplate Conduc Adhes Disp Ele	3M Company	GEI	Class II	1990-02-13
K900033	Micro-Aire Powered Micro-Surgery Instruments	Micro-Aire Surgical Instruments, Inc.	GEY	Class I	1990-02-13
K897187	Probe Patient Examination Gloves	Glove India Pvt., Ltd.	LYY	Class I	1990-02-13
K897040	Luxar Endoguide CO2 Laser Waveguide (Neuro.)	Luxar Corp.	GEX	Class II	1990-02-13
K896997	Atrauclip (Titanium Hemostatic Clip)	S.P.K. Technology, Inc.	FZP	Class II	1990-02-13
K896866	Luteinizing Hormone-Eia-Xt	In Vitro Diagnostics, Inc.	CEP	Class I	1990-02-13
K896863	Digoxin-Eia-Xt	In Vitro Diagnostics, Inc.	KXT	Class II	1990-02-13
K896838	Bistat Electrosurgical Unit 60-5400-001	Aspen Laboratories, Inc.	GEX	Class II	1990-02-13
K896515	Laserflo Blood Perfusion Monitor, Model Bpm2	Tsi, Inc.	DPW	Class II	1990-02-13