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 2026-11-05, 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 1914 of 3531

510(k) clearances, page 1914 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964257	Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) Reagent	Beckman Instruments, Inc.	LKL	Class I	1997-03-24
K963587	Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)	Wrightmedicaltechnologyinc	MQV	Class II	1997-03-24
K962343	Toxo Igg Elisa Test	Gull Laboratories, Inc.	LGD	Class II	1997-03-24
K954301	Abbott Cmv Total Antibody Eia (Modification)	Abbott Medical	LFZ	Class II	1997-03-24
K970721	Dyna-Flex Multi-Layer Compression System	Johnson & Johnson MEDICAL GmbH	MCY	Class II	1997-03-21
K970693	Acryderm Gel Wound Dressing	Acrymed, Inc.	MGQ	Unclassified	1997-03-21
K970640	Philips Easy Diagnost	Philips North America LLC	IXR	Class II	1997-03-21
K970633	Tustex Flavored Condoms	Line One Laboratories	HIS	Class II	1997-03-21
K970518	Algoplaque Hydrocolloid Dressing	Laboratoires Urgo	MGP	Unclassified	1997-03-21
K970293	Fuji Computed Radiography Fcr/dicom Gateway Unit Cr-Dm666	FUJIFILM Healthcare Americas Corporation	LMD	Class I	1997-03-21
K970247	Smith & Nephew Images Arthroscope/ent Endoscope	Smith & Nephew, Inc.	EOB	Class II	1997-03-21
K970232	Femtex 100% Cotton Dentle Touch Tampons	Regu-Tech Assoc., Inc.	HEB	Class II	1997-03-21
K970202	Depuy Ace Aim Titanium Tibial Nail	Depuy Ace Medical Co.	HSB	Class II	1997-03-21
K970134	Thermaprep Plus Oven	Tulsa Dental Products LLC	EKM	Class I	1997-03-21
K965181	Ces Infusion Catheter	Cordis Neurovascular, Inc.	KRA	Class II	1997-03-21
K965174	Trufill Pva Particles	Cordis Neurovascular, Inc.	HCG	Class II	1997-03-21
K965120	Allclenz Wound Cleanser	DPT Laboratories, Ltd.	KMF	Class I	1997-03-21
K964690	Liberty Valve	Cleveland Medical Devices, Inc.	KNX	Class II	1997-03-21
K964522	Ellipse 4	Andromeda Medizinische Systeme GmbH	FEN	Class II	1997-03-21
K964167	Decision Support System (for Radiation Oncology)	Multidata Systems International Corp.	IYE	Class II	1997-03-21
K964003	Metagen All Poly Acetabular Cup System	Metagen, LLC	JDI	Class II	1997-03-21
K963057	Fukuda Denshi Model Lx-3240 ECG & Respiratory Transmitter	Fukuda Denshi USA, Inc.	DSI	Class II	1997-03-21
K962376	Kreativ Kuring Light System	Kreativ, Inc.	EBF	Class II	1997-03-21
K962010	Epi-Scope Option for Q Series CT Systems	Philips North America LLC	LLZ	Class II	1997-03-21
K970020	Simar, Inc. Surgical Dressing	Simar, Inc.	EFQ	Unclassified	1997-03-20
K965132	Hi-Lo Evac and Evac II Endotracheal Tubes	Mallinckrodt Medical	BTR	Class II	1997-03-20
K965121	Cannula	Origin Medsystems, Inc.	HET	Class II	1997-03-20
K964954	Superlight	Wheelcare Scooters, Inc.	INI	Class II	1997-03-20
K964877	Impra Eptfe Arteriovenous Cuffed Graft	Impra, Inc.	DYF	Class II	1997-03-20
K964336	Cms Accuprobe 610, 620, 630, 640, 650, 660, 670, 680	Cryomedical Sciences, Inc.	GEH	Class II	1997-03-20
K963813	Sure Core Biopsy Kit	Interventional Concepts, Inc.	KNW	Class II	1997-03-20
K963698	Cm02 Cuvette, 1/2, Cm02 Cuvette, 3/8 and Cm02 Cuvette, 1/4	International Biophysics Corp.	DTY	Class II	1997-03-20
K962565	Powered Wheelchair	Orthofab, Inc.	ITI	Class II	1997-03-20
K970615	Promed 55-G Soft Daily Wear Contact Lens	Bio-Med Devices, Inc.	LPL	Class II	1997-03-19
K970489	Comeg Endoscopy Grasping Forceps	Comeg Endoscopy	FFL	Class II	1997-03-19
K970041	Ascend Balloon Dailation Catheter	Cook Incorporated	EZN	Class II	1997-03-19
K965238	T1 Control High Speed Dental Handpiece	Siemens Corp.	EFA	Class I	1997-03-19
K965190	Sensititre Haemophilus/streptococcus Pneumoniae Mic Plate	Accumed Intl., Inc.	JWY	Class II	1997-03-19
K965165	Cuttersil Comfort Hardener	Kulzer GmbH	ELW	Class II	1997-03-19
K965163	Cuttersil Comfort	Kulzer GmbH	ELW	Class II	1997-03-19
K965125	Dakota Smith, Nicole Miller Sunglasses	California Design Studio, Inc.	HQY	Class I	1997-03-19
K965093	Omnitech Resectoscope Roller Electrode	Omnitech Systems, Inc.	FAS	Class II	1997-03-19
K965085	Enzymun-Test Psa	Boehringer Mannheim Corp.	LTJ	Class II	1997-03-19
K964737	Hydroprep Gel	D.O. Weaver Co.	GYB	Class II	1997-03-19
K964224	Stainless Steel Cortac Cortical Electrode(2111)/plantinum Cortac Cortical Electrode	PMT Corp.	GYC	Class II	1997-03-19
K964199	Chase Coronary Sinus Perfusion Cannula	Chase Medical, Inc.	DWF	Class II	1997-03-19
K964198	Cahse Aortic Root Cannula	Chase Medical, Inc.	DWF	Class II	1997-03-19
K964195	Chase Two Stage Venous Return Catheter	Chase Medical, Inc.	DWF	Class II	1997-03-19
K964047	Cryosil Silicone Gel Sheeting	Biodermis LLC	GEH	Class II	1997-03-19
K963994	Narkomed Gs Anesthesia System	Draeger, Inc.	BSZ	Class II	1997-03-19