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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3196 of 3528

510(k) clearances, page 3196 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822970	Holter Recorder	Agilent Technologies, Inc.	DSH	Class II	1982-11-03
K822861	Lifeline 4800-C Digital Spirometer	Lifeline Controls	BZG	Class II	1982-11-03
K822776	Teflon Cannula	Cardiac Pacemakers, Inc.	FOZ	Class II	1982-11-03
K822775	Infus. Sets-9120-50 Cm & 9121-100 Cm,ext	Cardiac Pacemakers, Inc.	FPA	Class II	1982-11-03
K822774	9110 Syringe	Cardiac Pacemakers, Inc.	FMF	Class II	1982-11-03
K822744	#St10 Progr. Evoked Response Stimulator	Teca, Inc.	GWF	Class II	1982-11-03
K822711	Anti-Mist, Anti-Fog Eyeglass & Dental	Parker Laboratories, Inc.	FAX	Class I	1982-11-03
K822649	Device for the Treatment of Hemorrhoids	Dunmore Corp.	LKX	Unclassified	1982-11-03
K822464	Obturation Gutta	U.S. Shizai Corp.	EKA	Class I	1982-11-03
K822437	Monaghan Aerochamber	Monaghan Medical Corp.	BYP	Class I	1982-11-03
K822340	Extracorporeal Single Needle Module	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1982-11-03
K822159	Angiourography Kit	Mallinckrodt Critical Care	FMF	Class II	1982-11-03
K822088	Male Condom	Schmid Laboratories, Inc.	HIS	Class II	1982-11-03
K820775	Vestibulariset	JEDMED Instrument Company	ETP	Class I	1982-11-03
K823017	Intravenous Catheter Placement Unit &	Access Devices, Inc.	FOZ	Class II	1982-11-01
K823014	Digoxin Kit	Pcl-Ria, Inc.	DPB	Class II	1982-11-01
K823007	Opticath Heparin Coated, Flow-Direct	Oximetrix, Inc.	DYG	Class II	1982-11-01
K822972	Il 801 Thermaldilution Cardiac Output	Instrumentation Laboratory Co.	DXG	Class II	1982-11-01
K822961	Porta Fib III	Narco Scientific	LDD	Class II	1982-11-01
K822955	Model 4242 Tele Syst Arrhythmia Monitor	Medtronic, Inc.	DXH	Class II	1982-11-01
K822952	560	Kone Instruments, Inc.	DRT	Class II	1982-11-01
K822935	Thyroid Stimulating Hormone	Pcl-Ria, Inc.	JLW	Class II	1982-11-01
K822930	Csm Chromogenic B-Lactamase Disc	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1982-11-01
K822917	Model 5400 Optokinetic Stimulator	Life-Tech Intl., Inc.	HOW	Class I	1982-11-01
K822909	Pulse Oximeter Model 100	Nellcor, Inc.	DQA	Class II	1982-11-01
K822907	Kalos-03 Bipolar	Biotronik Sales, Inc.	DXY	Class III	1982-11-01
K822903	Autoecho	Oxford Medilog, Inc.	DXG	Class II	1982-11-01
K822892	Cortisol Ria Kit	Antibodies, Inc.	CGR	Class II	1982-11-01
K822870	Stool-Collection/preservation Kit	American Scientific Products	KDT	Class I	1982-11-01
K822834	Access Percutaneous Introducer Set	Access Devices, Inc.	DYB	Class II	1982-11-01
K822806	Balloon Wedge Pressure, Angiographic	Nova Medical Specialties	DYG	Class II	1982-11-01
K822803	Blood Oxygenators #Bos-105S Bos-5S W/	Bentley Laboratories, Inc.	DTZ	Class II	1982-11-01
K822750	Medi-Trace 5' Offset Electrode	Graphic Controls Corp.	DRX	Class II	1982-11-01
K822606	Cytomegalovirus Antobody Igg	Immulok, Inc.	LIN	Class II	1982-11-01
K822432	Centurion Chart Recorder	Clinical Data, Inc.	DSF	Class I	1982-11-01
K822393	Intraoperative Balloon Dilation Cath.	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1982-11-01
K822124	Titan Gel Cpk Isoenzyme System	Helena Laboratories, Corp.	JHT	Class II	1982-11-01
K822055	Cnibp Blood Pressure Measurement Sys	Ohio Medical Products	DXN	Class II	1982-11-01
K821477	Wm. Harvey H-1300 Infant/pediatric Blood	C.R. Bard Inc	DTZ	Class II	1982-11-01
K820729	Sarns Pulsatile Pump	3M Health Care, Sarns	DWB	Class II	1982-11-01
K822828	Soft Lens Thermal Disinfecting Unit, a-C	Safeway Products, Inc.	HRD	Class II	1982-10-29
K823037	Pleur-Evac a-4005 System	Howmedica Corp.	GCX	Class II	1982-10-28
K822831	Ri 300 Differential Temperature Monitor	Instrumentation Industries, Incorporated	FLL	Class II	1982-10-28
K822213	Siemens-Elema Ab Aga Revivator	Siemens Elema AB	BTM	Class II	1982-10-28
K823003	Q65 Medical Treadmill	Quinton, Inc.	IOL	Class I	1982-10-27
K822992	People Mover	Convaid Products LLC	INM	Class I	1982-10-27
K822982	Midas 100 Hemacolor Stain #66030	EMD Millipore Corporation	HYB	Class I	1982-10-27
K822981	Midas 1000 Wright Giemsa Stain #66020	EMD Millipore Corporation	IAF	Class I	1982-10-27
K822980	Midas 1000 Wright Stain #66010	EMD Millipore Corporation	IAF	Class I	1982-10-27
K822943	Ellison Vitallium Fixation Staple Sys	Howmedica Corp.	JDR	Class II	1982-10-27