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 2609 of 3530

510(k) clearances, page 2609 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893695	Patient Exam Gloves(mfg: Shanghai Hua Ling Lat Fac	Shanghai Industrial Investment Co., Ltd.	LYY	Class I	1989-09-13
K893618	Patient Examination Gloves	Tenma Co., Ltd.	LYY	Class I	1989-09-13
K893607	Patient Examination Gloves	Wedana Rubber Products	LYY	Class I	1989-09-13
K893593	Patient Examination Gloves	Strong Will Sdn Bhd	LYY	Class I	1989-09-13
K893306	Latex Examination Gloves	Acefit Intl., Inc.	LYY	Class I	1989-09-13
K893304	Latex Examination Gloves	Lakewood Ent., Ltd.	LYY	Class I	1989-09-13
K893303	Latex Examination Gloves	Marble King Corp.	LYY	Class I	1989-09-13
K893302	Latex Examination Gloves	Gromax Rubber Industry Co., Ltd.	LYY	Class I	1989-09-13
K893293	Latex Examination Gloves	Toptech Industry Corp.	LYY	Class I	1989-09-13
K893292	Latex Examination Gloves	Mahagewang Sdn Bhd	LYY	Class I	1989-09-13
K893158	Topclean Patient Examination Gloves	Pt. Herlin Dharma Persada	LYY	Class I	1989-09-13
K893155	Latex Examination Gloves	Success Development (USA) Co., Inc.	LYY	Class I	1989-09-13
K893154	Latex Examination Gloves	Magna Intl., Inc.	LYY	Class I	1989-09-13
K893115	Latex Examination Gloves	Naturub Sdn. Bhd.	LYY	Class I	1989-09-13
K892953	Patient Examination Gloves	Masju Sdn. Bhd.	LYY	Class I	1989-09-13
K892878	Kontron Intra-Aortic Balloon Pump Model K9000	Kontron Instruments, Inc.	DSP	Class II	1989-09-13
K892774	Patient Examination Gloves	Liaoning-Usa Corp.	LYY	Class I	1989-09-13
K892771	Patient Examination Gloves (Poly)	P.A. Research Corp.	LZA	Class I	1989-09-13
K892754	Patient Examination Gloves (Vinyl)	Baxter Healthcare Corporation	LYZ	Class I	1989-09-13
K892486	Uni-Lab Patient Examination Gloves (Latex)	Unicable	LYY	Class I	1989-09-13
K892297	Patient Exam Gloves (Mfg. Eaton Rubber Gloves Co.)	B.Y.K. Trading, Inc.	LYY	Class I	1989-09-13
K892290	Patient Examination Gloves (Natural Feelings)	B.Y.K. Trading, Inc.	LYY	Class I	1989-09-13
K892202	Detectadot(tm) System 2000 Rubella Igg Test	Gull Laboratories, Inc.	LFX	Class II	1989-09-13
K892107	Patient Examination Gloves (Latex)	Success Development (USA) Co., Inc.	LYY	Class I	1989-09-13
K891856	Super Gloves Patient Exam Gloves (Latex)	World Wide Trade Network, Inc.	LYY	Class I	1989-09-13
K891723	Patient Examination Gloves (Latex)	Khoo Chemical Industrial Sdn Bhd	LYY	Class I	1989-09-13
K891669	Patient Examination Glove (Latex)	Beauty Thai Rubber Chemical Co., Ltd.	LYY	Class I	1989-09-13
K891336	Patient Examination Gloves (Vinyl)	Kaohsiung Brothers Products Corp.	LYZ	Class I	1989-09-13
K891326	Patient Examination Gloves (Latex)	Medigloves, Ltd.	LYY	Class I	1989-09-13
K891122	Disp. Accessory to External Trans. Cardiac Pace.	Big Valley Medical	LDD	Class II	1989-09-13
K885319	Non-Sterile Exam Gloves	Straitscom	LYY	Class I	1989-09-13
K895219	Cancellous Screw Long Thread Diameter 6.5Mm	Mizuho Orthopedic Systems Inc	HWC	Class II	1989-09-12
K895218	Cancellous Screw Short Thread Diameter 6.5Mm	Mizuho Orthopedic Systems Inc	HWC	Class II	1989-09-12
K895217	Cortical Screw	Mizuho Orthopedic Systems Inc	HWC	Class II	1989-09-12
K895173	Skeletal Fixation Pin	Kronner Medical	JDW	Class II	1989-09-12
K895172	Kronner Sacral Pin Guide	Kronner Medical	LXH	Class I	1989-09-12
K894995	Latex Patient Examination Gloves	Orient Commercial Co., Ltd.	LYY	Class I	1989-09-12
K894979	Latex Patient Examination Gloves	Tower Rubber Industries Sdn. Bhd.	LYY	Class I	1989-09-12
K894974	Mobile Rx-4000 Magnetic Resonance Imaging System	Resonex, Inc.	LNH	Class II	1989-09-12
K894972	Unicare Latex Examination Gloves	Pt. Indorub Nusaraya	LYY	Class I	1989-09-12
K894905	Face Protection Pak(tm)	Protech Products	FXX	Class II	1989-09-12
K894842	Imed Gemini 12 Nonvented Y-Type Blood/solution Adm	Imed Corp.	FPA	Class II	1989-09-12
K894682	Usci Uncoated Guiding Catheters	C.R. Bard Inc	DQY	Class II	1989-09-12
K894516	Visoshield(tm), Surgical Eye Protector	Polamedco, Inc.	FXX	Class II	1989-09-12
K894479	30Kw High Freq. Radio. Gene. Models Hfq-30/Hfq30se	Bennett X-Ray Corp.	IZO	Class I	1989-09-12
K894383	Disposable Shoe Cover	American Threshold Industries, Inc.	FXP	Class I	1989-09-12
K894335	Model #535 Pacu Stretcher/bed & #530 Ed/trauma Str	Midmark Corp	FMF	Class II	1989-09-12
K894330	Daig Vessel Dilator	Daig Corp.	DRE	Class II	1989-09-12
K894217	Syringe Tip Adaptor	Acacia, Inc.	FMF	Class II	1989-09-12
K894186	Surgiflex Laser Contact Tips	Cabot Medical Corp.	GEX	Class II	1989-09-12