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 2518 of 3531

510(k) clearances, page 2518 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902563	Monoscopy(tm) Brand, Trocar Reducer Set	Dexide, Inc.	HET	Class II	1990-09-04
K902313	Lm-1Z Zoom Scope	Leisegang Medical, Inc.	HEX	Class II	1990-09-04
K902176	Silver Mactrode	Marquette Electronics, Inc.	DRX	Class II	1990-09-04
K902062	PEEP Valve	Hudson Oxygen Therapy Sales Co.	BYE	Class II	1990-09-04
K901658	Add'l Transducer for Use W/eub-165 Ultrasound	Hitachi Medical Corp. of America	DXK	Class II	1990-09-04
K901657	Add'l Transducer for Use W/eub-565 Ultrasound	Hitachi Medical Corp. of America	DXK	Class II	1990-09-04
K901393	Mainz Head Fixation by Perneczky	Zeppelin GmbH	HBL	Class II	1990-09-04
K900472	Skytron Model 860 and 800 Comp. Surgita Neuro Equi	Skytron, LLC	HBN	Class I	1990-09-04
K900331	Tuba Tm (Transit-Time Ultrasonic Breath Analyzer)	Ghg Medizin-Elektronik AG	BZG	Class II	1990-09-04
K900208	Zerowet Splashield	Zerowet Splashield	KYZ	Class I	1990-09-04
K893060	Medi, Curi Exam Gloves	Golden Charter, Ltd.	LYY	Class I	1990-09-04
K903544	Carekits(tm) Incision/drainage/suture Removal Kits	J.J. Skinner, Inc.	LRP	Class I	1990-08-31
K903411	Field Medical Oxygen Gen/dist Sys-Battlefield Purp	Guild Assoc., Inc.	CAW	Class II	1990-08-31
K902514	Challenge 5010 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-08-31
K902513	Challenge 6010 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-08-31
K902512	Challenge 8000 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-08-31
K902511	Challenge 7010 Powered Muscle Stimulator	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1990-08-31
K901451	F-20 Cemented Metal-Backed Acetabular Cup	Med-Tek Corp.	JDI	Class II	1990-08-31
K900683	Seven Add'l Transducers for the Eub-450 Ultrasound	Hitachi Medical Corp. of America	ITX	Class II	1990-08-31
K896749	Piezon Master 400	E.M.S. - Electro Medical Systems SA	ELC	Class II	1990-08-31
K903853	Rapitex (R) Crp New	Behring Diagnostics, Inc.	DCN	Class II	1990-08-30
K903852	Rapitex(r) RF New	Behring Diagnostics, Inc.	DHR	Class II	1990-08-30
K903789	Avi Micro 885 Dual Channel Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-08-30
K903784	Avi Model 480Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-08-30
K903781	Avi Model 880 Dual Channel Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-08-30
K903685	Argident K Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903684	Argident 3 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903683	Argilite 2 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903682	Argilite 1 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903681	Argident Yellow 1 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903680	Argident Yellow 3 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-30
K903554	Nortech Model 87202204 Electrode	Medtronic Andover Medical, Inc.	GXY	Class II	1990-08-30
K903395	Uromat 2000	Pausch Corp.	IXR	Class II	1990-08-30
K903193	Smith & Nephew Dyonics Levelert System	Smith & Nephew Dyonics, Inc.	FLN	Class II	1990-08-30
K903048	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1990-08-30
K902949	Corpak Grasping Forceps	Corpak Co.	OCZ	Class II	1990-08-30
K902624	Bd Flexible Digital Thermometer	BD Becton Dickinson Vacutainer Systems Preanalytic	FLL	Class II	1990-08-30
K902464	Chartermed Empty Tpn Container - 100 Ml Capacity	Chartermed, Inc.	KPE	Class II	1990-08-30
K902454	Cathscanner(r) Pta Balloon Dilatation Catheter	Endosonics Corp.	LIT	Class II	1990-08-30
K902444	Clearview(tm) Angioscopic Irrigation Pump	Intramed Laboratories, Inc.	DQI	Class II	1990-08-30
K901330	The Monitor Electronic Bed Alarm System	The Monitor Corp.	KMI	Class I	1990-08-30
K896757	Gambro Ak-10 Dialysis System for High Flows	Gambro, Inc.	FKP	Class II	1990-08-30
K896707	Perlink Screen, Kiran Screen	Perlink USA, Inc.	EAM	Class I	1990-08-30
K896134	Acuflo, Vacuum-Powered Body Fluid Suction Appara.	Goosen Enterprises, Inc.	GCX	Class II	1990-08-30
K894795	Hologic Qdr-1000/W X-Ray Bone Densitometer	Hologic, Inc.	KGI	Class II	1990-08-30
K903800	Fiber Optic Light Cable	Orlux Engineering and Instrumentation	FST	Class II	1990-08-29
K903686	Argilite 4 Gold Alloy for Porcelain	Argen Precious Metals, Inc.	EFT	Class I	1990-08-29
K903679	Argident Yellow 2 Gold Alloy for Procelain	Argen Precious Metals, Inc.	EJT	Class II	1990-08-29
K903550	Topcast	Argen Precious Metals, Inc.	EJT	Class II	1990-08-29
K903336	Customed Hip Pact	Customed, Inc	LRO	Class II	1990-08-29