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 3216 of 3528

510(k) clearances, page 3216 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821213	Uric Acid Reagent Set	Omega Medical Electronics	CDH	Class I	1982-07-13
K821210	Serum Total Protein Reagent Set	Omega Medical Electronics	CEK	Class II	1982-07-13
K821203	Hdl Precipitant Reagent Set	Omega Medical Electronics	LBR	Class I	1982-07-13
K821200	Alkaline Phosphotase Reagent Set	Omega Medical Electronics	CIO	Class II	1982-07-13
K821199	Creatinine Reagent Set	Omega Medical Electronics	CGX	Class II	1982-07-13
K821198	Direct Glucose Reagent Set	Omega Medical Electronics	CGE	Class II	1982-07-13
K821197	Total Bilirubin Reagent Set	Omega Medical Electronics	CIG	Class II	1982-07-13
K821196	Serum Calcium Reagent Set	Omega Medical Electronics	CIC	Class II	1982-07-13
K821195	Cholesterol Reagent Set	Omega Medical Electronics	CHD	Class I	1982-07-13
K821193	Albumin Reagent Set	Omega Medical Electronics	CIX	Class II	1982-07-13
K821070	Biomedical Fluoroptic	Luxtron	FLL	Class II	1982-07-13
K820666	Human C-Peptide of Insulin by Radioimm.	Immuno Nuclear Corp.	JKD	Class I	1982-07-13
K820336	Dako Pap Kit K509	Dako Corp.	LIJ	Class I	1982-07-13
K827609	Midwest Automatic Bucky Equipped with Grid and Size-O-Matic Tray	Midwest X-Ray Equipment Co.			1982-07-09
K827582	Modified X-Ray Table	Transworld X-Ray Corp.			1982-07-09
K827572	Adac Model Dps-6100 Multi Modality Digital Procesing Systems	Philips North America LLC			1982-07-09
K827571	Mobile Digital Receptor	Technicare Corp.			1982-07-09
K827543	Maxicamera Model 200A	General Electric Co.			1982-07-09
K827409	Real Time Ultrasound Scanner 1849	Bruel & Kjaer Instruments, Inc.			1982-07-09
K827380	Scanner Type 1846	Bruel & Kjaer Instruments, Inc.			1982-07-09
K827371	Cilco Ascan	Cilco, Inc.			1982-07-09
K827292	Model Ic 3000	Xonics Medical Systems, Inc.			1982-07-09
K821814	Hemo-Nate L-P Kit	Int'L Corp.	KDD	Class I	1982-07-09
K821749	Amsco Endoscopy Table	American Sterilizer Co.	GDC	Class I	1982-07-09
K821732	Argyle Gerzof Abcess Drainage Catheter	Sherwood Medical Co.			1982-07-09
K821705	Nagashima F60mm Attach. Lens	Kelleher Corp.	FXQ	Class I	1982-07-09
K821689	Lebanon Microscope	The Lebanon Corp.	EPT	Class I	1982-07-09
K821502	Sterile Suture Removal Kit	Pro-Pak	KDD	Class I	1982-07-09
K821220	Multilumen Intravenous Infusion Catheter	Clincal Instruments Corp.	GBP	Class I	1982-07-09
K821133	Electrical Vibrating Device	Durham Electric Co.	IRO	Class I	1982-07-09
K820696	Meadox Woven Double Velour	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1982-07-09
K821933	Omnisurg Side Mounting Clamp & Rail Ext.	Polamedco, Inc.	FWZ	Class I	1982-07-08
K821929	Subclavian	Dna Medical, Inc.	FOZ	Class II	1982-07-08
K821868	Ultrachem E-Glu	Harleco Diagnostics	CFR	Class II	1982-07-08
K821861	Coat-a-Count Insulin Kit	Siemens Healthcare Diagnostics Inc.	CFP	Class I	1982-07-08
K821845	Egg Yolk Agar (Plate)	Granite Diagnostics, Inc.	JSF	Class I	1982-07-08
K821726	Model 535-02 Trace-a-Pace Transmitter	Intermedics, Inc.	DXH	Class II	1982-07-08
K821597	Brain Heart Infusion	Hardy Media	JSC	Class I	1982-07-08
K821596	6.5% Nacl Broth	Hardy Media	JSJ	Class I	1982-07-08
K821595	Motility Test Medium	Hardy Media	JSH	Class I	1982-07-08
K821594	Urea Agar Slant	Hardy Media	JSF	Class I	1982-07-08
K821593	Bile Esculin Azide Broth	Hardy Media	JSF	Class I	1982-07-08
K821592	Triple Sugar Iron Agar Slant	Hardy Media	JSE	Class I	1982-07-08
K821557	Level I Control Serum	Irvine Scientific LLC	JJY	Class I	1982-07-08
K821535	Vitaline Disposable EKG Electrode-Lead	The Halverstadt Co.	DRX	Class II	1982-07-08
K821518	Myo/clip	Alto Development Corp	LDF	Class II	1982-07-08
K821491	35Mm Angiogram Viewer Analyzer	Birtcher Corp.	DXJ	Class II	1982-07-08
K821392	Model Tpc-1 Oxygen Analyzer	Marathon	CCL	Class II	1982-07-08
K821378	Non-Invasive Automatic Blood Pressure	Narco Scientific	DXN	Class II	1982-07-08
K821373	Xomed Patency Monitor	Xomed, Inc.	DPW	Class II	1982-07-08