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 3480 of 3526

510(k) clearances, page 3480 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770971	Cardiozyme Ck-Control Abnormal	Dade, Baxter Travenol Diagnostics, Inc.	JJT	Class I	1977-08-04
K770914	Incubator, Portable, Act-Stat	Thermolyne Corp.	KQG	Class II	1977-08-04
K770776	Tray, Pressure, Intracompartmental,wick	Cutter Laboratories, Inc.			1977-08-04
K770720	Tubing Pack, Extracorporeal, H-3000	William Harvey Life Products Corp.	BYS	Class II	1977-08-04
K770580	Peak Flow Meter	Projects in Health	BZH	Class II	1977-08-04
K770244	Auto Differential Cell Counter System	Abbott Medical	GKZ	Class II	1977-08-04
K771404	Nuva-Fil Composite Restorative (Modi.)	L.D. Caulk Co.	EBF	Class II	1977-08-03
K771396	Dispenser, Mercury & Tablet/powder	Johnson & Johnson Professionals, Inc.	EHE	Class I	1977-08-03
K771383	Alloy Dispos-a-Cap Dental School Cap	Johnson & Johnson Professionals, Inc.	EJJ	Class II	1977-08-03
K771379	Fetal Monitoring Sys. Model Fm3r	Sonicaid, Inc.	HGM	Class II	1977-08-03
K771370	Icrotaineo Brand Tube	BD Becton Dickinson Vacutainer Systems Preanalytic	GJE	Class II	1977-08-03
K771366	Interplants	Maurices J. Fagan, Jr. B.S., D.D.S.	DZE	Class II	1977-08-03
K771347	R&r Alston Carbide Burs	Ransom & Randolph. LLC.	EJL	Class I	1977-08-03
K771335	Creatinine Analyzer 2	Beckman Instruments, Inc.	CGX	Class II	1977-08-03
K771328	Uviobond	Espe GmbH (US)	KLE	Class II	1977-08-03
K771321	Hydron Burn Bandage	Abbott Medical	KMF	Class I	1977-08-03
K771314	Glucose Reagent (O-Toluidine)	Mallinckrodt Critical Care	CGE	Class II	1977-08-03
K771313	Cholesterol Reagent	Mallinckrodt Critical Care	CGO	Class I	1977-08-03
K771312	Blood Urea Nitrogen (Bun) Reagent	Mallinckrodt Critical Care	CDW	Class II	1977-08-03
K771311	Glucose Reagent (Hexohinase)	Mallinckrodt Critical Care	CFR	Class II	1977-08-03
K771310	Calcium Reagent	Mallinckrodt Critical Care	CIC	Class II	1977-08-03
K771309	Ria for Total Thyroxine	Abbott Medical	CDX	Class II	1977-08-03
K771298	6 L.l. System	Toshiba Medical Systems	JAA	Class II	1977-08-03
K771297	Tubestand Model Ds-Ta-4	Toshiba Medical Systems	IZF	Class II	1977-08-03
K771296	Tube Conveyor Model Ds-Pb-4	Toshiba Medical Systems	IZF	Class II	1977-08-03
K771295	X-Ray Generator Model Kx0-825	Toshiba Medical Systems	IZO	Class I	1977-08-03
K771294	X-Ray Generator Model Kxo-15	Toshiba Medical Systems	IZO	Class I	1977-08-03
K771293	X-Ray Diag. Table Dt-Kcs	Toshiba Medical Systems	IXR	Class II	1977-08-03
K771290	Contact Compount Sonolay. Sac-10A	Toshiba Medical Systems	IYO	Class II	1977-08-03
K771263	Radiomhter Osm-2 Hemoximeter	The London Co.	GHS	Class II	1977-08-03
K771260	Linear Accelerator G-2900	Atomic Energy of Canada	IYE	Class II	1977-08-03
K771243	Antisera to Human Fab Fragment	Kent Laboratories, Inc.	DFK	Class I	1977-08-03
K771242	Antisera to Human Fab Fragment	Kent Laboratories, Inc.	DDR	Class II	1977-08-03
K771236	Triobead-125 Diagnostic Kit	Abbott Medical	CEC	Class II	1977-08-03
K771235	Htsh Ria Human Thyroid Hormone Ria	Abbott Medical	JLW	Class II	1977-08-03
K771225	Ap Isotrol, #a 0140	Sigma Chemical Co.	CIN	Class II	1977-08-03
K771196	Marker Generator Modules - 21597A	Hewlett-Packard Co.	HGM	Class II	1977-08-03
K771195	Fetal/maternal Repeater - 21596A	Hewlett-Packard Co.	HGM	Class II	1977-08-03
K771194	Fetal/maternal Alrm Module - 21595A	Hewlett-Packard Co.	HGM	Class II	1977-08-03
K771180	Gamma Gounting Sys., Auto, Model 1400	G.D. Searle and Co.	JJJ	Class I	1977-08-03
K771121	Empty Admixture Containers	Medi, Inc.	KPE	Class II	1977-08-03
K771120	Impreflex Alginate Impression Material	Espe Dental Products	LEW	Class II	1977-08-03
K771008	Api 20C	Analytical Products, Inc.	JXB	Class I	1977-08-03
K770693	X-Ray Device, Mammographic Diagnostic	Xonics Medical Systems, Inc.	IZH	Class II	1977-08-03
K771367	Choledochoscope System	Richard Wolf Medical Instruments Corp.	FBN	Class II	1977-08-02
K771364	Lube Jel	Travenol Laboratories, S.A.	FHX	Class II	1977-08-02
K771349	Modification to Kidney Dialyzer	Erika, Inc.	FHS	Class II	1977-08-02
K771348	Econowrap Paper C.s.r. Wrap	Tower Products, Inc.	FRG	Class II	1977-08-02
K771339	Male Luer Lock Plug	American Viggo	FPA	Class II	1977-08-02
K771327	Uviofil	Espe GmbH (US)	EBC	Class II	1977-08-02