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 3442 of 3526

510(k) clearances, page 3442 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780854	In Vitro Neonatal T4	Clinical Assays, Inc.	CDX	Class II	1978-07-27
K780837	Urinary Drainage Bag	Intermed, Inc.	KNX	Class II	1978-07-27
K780831	Urinary Catheterization System W/o Foley	Medical Devices Inc.	KNX	Class II	1978-07-27
K780817	Globin-Terge	Simmler & Son, Inc.			1978-07-27
K780794	Irrigation Cap	Travenol Laboratories, S.A.	KYZ	Class I	1978-07-27
K780781	Stilith Cardiac Pacemakers-M. 60 & 120	R.E. Brown Co., Inc.	DXY	Class III	1978-07-27
K780774	Papillotomy Knives	Olympus Corp.	KNS	Class II	1978-07-27
K780766	(125 I) Digitoxin Ria Kit	Siemens Healthcare Diagnostics Inc.	LCW	Class II	1978-07-27
K780750	O2 Connector	Diemolding Corp.	CAN	Class I	1978-07-27
K780742	Intraoral Dental X-Ray Generator	Siemens Corp.	IZO	Class I	1978-07-27
K780652	Hemoglobin Check Solutions, S2100 Osm-2	The London Co.	JKS	Class I	1978-07-27
K780561	Ventricular Inhibited Pulse Generator	Medtronic, Inc.	DXY	Class III	1978-07-27
K780455	Quantitative Determination of Porphyrins	Whale Scientific, Inc.	JKJ	Class I	1978-07-27
K780420	Generator, Pulse, Cardiac, Implantable	Telectronics, Inc.	DXY	Class III	1978-07-27
K780621	Lead, Pacing, Atrial, Endocardial, Tined	Medtronic, Inc.	DTB	Class III	1978-07-26
K780658	Sterile Blood Administration Set	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1978-07-19
K780657	Sterile Blood Collection Set	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1978-07-19
K780656	Sterile Infusion Set Type J	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1978-07-19
K780655	Sterile Infusion Set Type S	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1978-07-19
K780585	Surgical Laser	Laser Industries, Ltd.	GEX	Class II	1978-07-19
K781084	Therapax 150A	Emi Therapy Systems, Inc.	JAD	Class II	1978-07-18
K781040	CT Scanner Nd 8000	Cgr Medical Corp.	JAK	Class II	1978-07-18
K780986	Digital Blood Pressure Monitor	Sears, Roebuck & Co.	DXN	Class II	1978-07-18
K781112	Cast Wedge, Yancey	Orthopedic Equipment Co., Inc.			1978-07-17
K781107	Dispenser, Gas Xenon	Mallinckrodt Critical Care	IYT	Class II	1978-07-17
K781101	Electrosurgical Unit 75	Ritter GmbH	GEI	Class II	1978-07-17
K781096	Hearing Aid, Eyeglass, B-12	Argosy Intl. (USA), Inc.	ESD	Class I	1978-07-17
K781095	Hearing Aid, Behind the Ear	Argosy Intl. (USA), Inc.	ESD	Class I	1978-07-17
K781094	Hearing Aid, Eyeglass	Argosy Intl. (USA), Inc.	ESD	Class I	1978-07-17
K781091	Knee Instrumentation, Condylar	Zimmer GmbH	HWT	Class I	1978-07-17
K781089	One Incision Bi-Polar Electro. Forceps	Kli	HIN	Class II	1978-07-17
K781085	Assure Natural Fit Tampon	Personal Products Co.	HIL	Class II	1978-07-17
K781079	Sonograf Ultrasound B-Scanning System	Ohio Nuclear, Inc.	IYO	Class II	1978-07-17
K781068	Automatic Film Processorio M. R80	Tecnomed, Inc.	IWX	Class I	1978-07-17
K781067	Plurix B; Radiographic Table	Tecnomed, Inc.	IXQ	Class II	1978-07-17
K781066	Plurix C; Radiographic Table	Tecnomed, Inc.	IXQ	Class II	1978-07-17
K781065	Plurimat;radiographic Tube Mount	Tecnomed, Inc.	IYB	Class I	1978-07-17
K781057	Clinac 20 (Optional 18 Mv Version)	Varian Assoc., Inc.	IYE	Class II	1978-07-17
K781055	Face Tents	Hospitak, Inc.	BYG	Class I	1978-07-17
K781051	Emisonic 4201	Emi Medical, Inc.	IYO	Class II	1978-07-17
K781030	X-Ray Unit, Portable Gx-101 Aec	General X-Ray, Inc.	IZL	Class II	1978-07-17
K780984	PVC Quick Prime Lines	Norton Performance Plastics Corp.	KRI	Class I	1978-07-17
K780939	Bard-Parker Arterial Monitoring System	BD Becton Dickinson Vacutainer Systems Preanalytic	CBT	Class I	1978-07-17
K780900	Slick Set	Polamedco, Inc.	BTR	Class II	1978-07-17
K780838	Perci	Micro Tronics Corp.	BXX	Class I	1978-07-17
K780765	Percutaneous Surapubic Catheter	Vance Products, Inc.	KOB	Class II	1978-07-17
K780738	Pentax St-1A	Hal-Hen Co., Inc.	DQD	Class II	1978-07-17
K780715	Aneroid Type Blood Pressure Kit	Mars Metal Co., Ltd.	DXQ	Class II	1978-07-17
K780708	Automatic Retractor Holder	Great Eastern Lumber Co., Inc.	GAD	Class I	1978-07-17
K780703	Cuff Pacer	Omp Laboratories, Inc.	CBA	Class II	1978-07-17