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 2297 of 3531

510(k) clearances, page 2297 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931213	Acs Digoxin Immunoassay	Ciba Corning Diagnostics Corp.	KXT	Class II	1993-06-07
K930477	Acs Angiotensin Converting Enzyme (Ace) Calibrator	Analytical Control Systems	JIS	Class II	1993-06-07
K930010	Access Thyroid Uptake Assay	Bio-Rad Laboratories Inc.	CEE	Class II	1993-06-07
K926500	Uc Qik Pregnancy Test	Eucardio Laboratory, Inc.	JHI	Class II	1993-06-07
K926271	Schneider Match-35 Percutaneous Transluminal Angio	Schneider Intl., Ltd.	LIT	Class II	1993-06-07
K926131	Opus Magnum Analyzer	Pb Diagnostic Systems, Inc.	KHO	Class I	1993-06-07
K926109	Fluid Drainage Tray	Boston Scientific Corporation	GBX	Class I	1993-06-07
K926063	Per-Q-Cath Dressing Change Tray	Gesco Intl., Inc.	MCY	Class II	1993-06-07
K926031	Pro-Prep i.v. Start/scrub-Prep/blood Culture Kit	Brigam Medical, Inc.	LRS	Class II	1993-06-07
K926003	Schneider Softip Sst Angiographic (Diag) Catheter	Schneider Intl., Ltd.	DQO	Class II	1993-06-07
K925076	Sarns Turbo Membrane Oxygena. W/int. Cardiotomy R.	3M Health Care, Sarns	DTZ	Class II	1993-06-07
K925075	Sarns Turbo Membrane Oxygena. W/int. Reservoir	3M Health Care, Sarns	DTZ	Class II	1993-06-07
K925021	Tpn Tray (Sterile)	Customed, Inc	MCY	Class II	1993-06-07
K925015	Sterile Suture Removal Kit	Customed, Inc	MCZ	Class I	1993-06-07
K924958	Biopsy/myelo/arthro/amniocent/basic Skin Prep Tray	Medical Insights, Inc.	KDD	Class I	1993-06-07
K924891	Plexus Pulser I, Plexus Pulser II	Dobre, Inc.	JOW	Class II	1993-06-07
K924809	Irrigation Tray W/ Bulb Syringe	Customed, Inc	KYZ	Class I	1993-06-07
K924773	Burton H- Base Table - Model 1990	R.H. Burton Co.	HRX	Class II	1993-06-07
K924204	New Ultrasound Imaging System & Transducers	Tetra Corp.	IYN	Class II	1993-06-07
K924152	Keystone Concentrator, Model Pv5l	Devilbiss Health Care, Inc.	CAW	Class II	1993-06-07
K923778	Sunglasses	Cyrk Intl., Inc.	HQY	Class I	1993-06-07
K923031	Endosnare	Cook Incorporated	FDI	Class II	1993-06-07
K922133	Hospital Kit Sv 105	Savoy Medical Supply Co., Inc.	LRO	Class II	1993-06-07
K921950	Surgical Dynamics Discography System	Surgical Dynamics Ltd	FMI	Class II	1993-06-07
K920755	L-Cath Peel Away System Catheter	Luther Medical Products, Inc.	LJS	Class II	1993-06-07
K931424	Maxima I	Staodyne, Inc.	GZJ	Class II	1993-06-04
K931171	Doc-Tite(tm) Guide Wire Extension	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1993-06-04
K930570	Radioactive Palladium 103 Seeds/sources	Best Industries	KXK	Class II	1993-06-04
K930464	Blunt Dissecting Scissors	Surgical Technologies, Inc.	GCJ	Class II	1993-06-04
K930294	Patpos Green	Cp Bio-Medical Corp.	IWE	Class I	1993-06-04
K926233	Cardio2 Cycle	Ergometrix, Inc.	KRI	Class I	1993-06-04
K925710	M.e.d. Light	Medical Illumination, Inc.	KZF	Class I	1993-06-04
K925683	Non-Sterile Latex Examination Gloves(pre-Powdered)	Arista Latindo Industrial, Ltd. P.T.	LYY	Class I	1993-06-04
K925576	Burke Bariatric Treatment System II	Burke Mobility Products	FNL	Class II	1993-06-04
K925417	Kendall Home Rx Therapeutic Stocking	Kendall Healthcare Products Co. Div.Of Tyco Health	DWL	Class II	1993-06-04
K925242	Apollo(tm) Knee System	Intermedics Orthopedics	JWH	Class II	1993-06-04
K924941	Concept 4Mm Cancellous Screw with Eyelet	Linvatec Corporation	JDR	Class II	1993-06-04
K924647	Dlr-1 Derma-Lase Ruby Laser/dlr-1/Derma-Lase Syst	Derma-Lase Co.	GEX	Class II	1993-06-04
K924290	Best Industries Cartridge & Gun	Best Industries	IWJ	Class I	1993-06-04
K924261	Radioactive Cesium-131 Seeds/sources	Best Industries	KXK	Class II	1993-06-04
K922637	Horizon Pump Y-Type Blood Set	Mcgaw, Inc.	FPA	Class II	1993-06-04
K931289	Remel Cefpodoxime 10 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1993-06-02
K931269	Lead Apron	Bt Medical Co., Inc.	EAJ	Class I	1993-06-02
K930311	Cvis Longview	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1993-06-02
K926422	Vista(r) Human Follicle-Stim Hormone(hfsh) Assay	Syva Co.	GGJ	Class I	1993-06-02
K926357	Medtronic Bio-Medicus Handcrank Model 150	Medtronic Bio-Medicus, Inc.	DWA	Class II	1993-06-02
K925580	Ohmeda Tec 6 (Cfv) Continuous Flow Vaporizer, Nad	Ohmeda Anesthesia Systems Therapy Group	BSZ	Class II	1993-06-02
K932187	Prone Positioner	voss medical products	KIL	Class I	1993-06-01
K932186	Bypass Leg Positioner	voss medical products	FQO	Class I	1993-06-01
K931161	Series Star 22 - Behind the Ear Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1993-06-01