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 2026-11-02, 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 2514 of 3531

510(k) clearances, page 2514 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902692	Diagnostic Ultrasound/uro-Gyn Uds 1002	Diagnostic Ultrasound Corp.	FAP	Class II	1990-09-13
K902653	Pds-2000	Intl. Equipment and Supply Corp.	EIK	Class I	1990-09-13
K901734	Serim Residual Chlorine Test Kit	Serim Research Corp.	FKJ	Class II	1990-09-13
K897042	Eub-515 Diagnostic Ultrasound Device	Hitachi Medical Corp. of America	IYO	Class II	1990-09-13
K896701	Teflon Cervical Access Set	Cook Ob/Gyn	HDQ	Class I	1990-09-13
K903856	Wet-No-More Monitor	Travis Industries, Inc.	KPN	Class II	1990-09-12
K903833	Dentabond Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903832	Argicraft 2 Palladium Silver Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903831	Argicraft 1 Palladium Silver Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903830	Novabond Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903819	Argistar 45 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903818	Argibond Dental Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-09-12
K903758	Syva Microtrak Eia Accessory Reagents	Syva Co.	LJC	Class I	1990-09-12
K903744	Physician's Choice	Advance Medical Device, Inc.	HIB	Class II	1990-09-12
K903696	Olympus Inorganic Phosphorus	Em Diagnostic Systems, Inc.	CEO	Class I	1990-09-12
K903669	Genesis Insufflating Catheter	General Medical Co.	BSY	Class I	1990-09-12
K903602	Espi Non-Insulated Double-Action Grasper, #8203	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903601	Espi Non-Insulated Double-Action Grasper #8204	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903597	Espi Micro Scissors, #8150	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903596	Espi Reducer Sleeve, #8415	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903595	Espi Claw Forcep, #8302, 10Mm, 30Cm	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903594	Espi Tissue Grasper/needle Holder, #8201	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903593	Espi Applicator Sleeve, #8410	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903592	Espi Claw Forcep, #8301, 5Mm, 30 Cm Length	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903591	Espi Hook/universal Scissors, # 8101	Dixon Medical, Inc.	HET	Class II	1990-09-12
K903501	Radiant Temperatur Indicator Model 25E	Medical Systems Corp.	FLL	Class II	1990-09-12
K903449	Uresil Tru-Close Multi-Purpose Drainage Set	Uresil, LLC	EXF	Class II	1990-09-12
K903289	Patient Examination Gloves	Pacificlink Export Industries Private, Ltd.	LYY	Class I	1990-09-12
K903201	Accuprobe Blastomyces Dermatit Cult Confirm Test	Hologic, Inc.	MDC	Class II	1990-09-12
K903198	Alanine Aminotransferase Test	Em Diagnostic Systems, Inc.	CKA	Class I	1990-09-12
K903073	Latex Finger Cots	Dongkuk Trading Co., Ltd.	LZB	Class I	1990-09-12
K903024	Bi-O.k. Steam Test-Pak	Propper Mfg Co Inc	FRC	Class II	1990-09-12
K902945	Cope Nitinol Stone Basket	Cook Inc.	LQR	Class II	1990-09-12
K902944	Wittich Nitinol Stone Basket	Cook Inc.	LQR	Class II	1990-09-12
K902883	Tissue/polyp Trap System	Triton Technology, Inc.	BYZ	Class II	1990-09-12
K902788	Clem Tm	Arbo Medical, Inc.	FIB	Class II	1990-09-12
K902784	Fiber Optic Light Source	Trek Medical Products, Inc.	EQH	Class I	1990-09-12
K902742	Degufill (Tm) Whit-Sealant	Degussa AG	EBC	Class II	1990-09-12
K902684	Mic Anal Incontinence Tube	Medical Innovations, Inc.	KNT	Class II	1990-09-12
K902527	Split-Second Introducer	BD Becton Dickinson Vacutainer Systems Preanalytic	FOZ	Class II	1990-09-12
K902371	Haelan 340 Muscle Stimulator	Paranamics, Inc.	IPF	Class II	1990-09-12
K902285	The Magnum Chin Implant	Applied Biomaterial Technologies	FWP	Class II	1990-09-12
K902284	Zymalar Implant	Applied Biomaterial Technologies	LZK	Class II	1990-09-12
K902252	Rastronics Cci 10/3 Hearing Aid Analysis	Rastronics USA, Inc.	ETW	Class II	1990-09-12
K902141	Anolift - Portable & Anolift - Gantry	Anodyne	FSA	Class I	1990-09-12
K901969	Alert Bed Alarm System	Alertronics, Inc.	KMI	Class I	1990-09-12
K901949	IV Set	Jfv, Inc.	FPA	Class II	1990-09-12
K901907	Professional Monitor	Travis Industries, Inc.	KPN	Class II	1990-09-12
K901840	(Eia) for Igm Antibody to Ebv Vca in Human Serum	Granbio, Inc.	LJN	Class I	1990-09-12
K901509	Trauma Sleeve	Haz-Med, Inc.	KME	Class I	1990-09-12