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 976 of 3531

510(k) clearances, page 976 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103772	Vinyl Examination Glove Powder Free (Clear, Non-Colred) /Yellow/white)	Advanced Medical Devices Factory	LYZ	Class I	2011-02-25
K103528	Ips Empress Direct Flow	Ivoclar Vivadent, Inc.	EBF	Class II	2011-02-25
K103449	Brachytherapy Needles, Rp Sleeve, Rp Brachy-Spacer, Gold Makers	Riverpoint Medical, LLC	KXK	Class II	2011-02-25
K103397	Accuvix Xg Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2011-02-25
K103337	Multiple Name	Ideal Quality Sdn Bhd	LZA	Class I	2011-02-25
K103222	Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	FRC	Class II	2011-02-25
K103185	Toshiba 1.5T Extra Large Knee Coil	Quality Electrodynamics	MOS	Class II	2011-02-25
K103004	Snore Guard	Ranir, LLC	LRK	Class II	2011-02-25
K102947	Non-Contact Infrared Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	2011-02-25
K102532	Hls Cannula Non-Coated, with Bioline Coating and with Softline Coating	MAQUET CARDIOPULMONARY GmbH	DWF	Class II	2011-02-25
K102482	Flash Pta Balloon Dilatation Catheter 5Mm X 19Mm X 135Cm; Flash Pta Balloon Dilatation Catheter 6Mm X 19Mm X 135Cm	Verge Medical Inc.	LIT	Class II	2011-02-25
K102375	Lucia	Meridian AG	ILY	Class II	2011-02-25
K102223	Challenge-Ever	Hallim Dentech Co., Ltd.	EIA	Class I	2011-02-25
K100954	Adapt, Model Ax-03Sn	Apeliotus Vision Science, Inc.	OUM	Class I	2011-02-25
K100799	Fortress Introducer Sheath System Model 358813, 358814, 358815	Contract Medical Intl. GmbH	DYB	Class II	2011-02-25
K093884	Roche Fludi Methamphetamine	Roche Diagnostics GmbH	LAF	Class II	2011-02-25
K092755	Sterraad 100Nx Express Cycle Test Pack	Advanced Sterilization Products	FRC	Class II	2011-02-25
K110193	Femostop Plys, Femostop Hd, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch, Bilateral Adapter; F	St. Jude Medical Systems AB	DXC	Class II	2011-02-24
K110080	Radial-Emitting Shaped Fiber Optic Delivery System	Biolitec, Inc.	GEX	Class II	2011-02-24
K110012	Illumigene C. Difficile, and Illumipro-10	Meridian Bioscience Inc	OMN	Class I	2011-02-24
K103535	Vacplus Suction Unit	Apex Medical, Inc.	JCX	Class II	2011-02-24
K103478	Single Use Biliary Drainage Stent V	Olympus Medical Systems Corp.	FGE	Class II	2011-02-24
K103280	Bhdental Implant System	Bhdental, Ltd.	NHA	Class II	2011-02-24
K103253	Sils Port	Coviden (Formerly Registered AS US Surgical, A Div	GCJ	Class II	2011-02-24
K103119	Billy Boy Male Latex Condom	Sheila Pickering PHD	HIS	Class II	2011-02-24
K103059	Trophon	Nanosonics Limited	OUJ	Class II	2011-02-24
K102597	Piccolo Composite Plate System	N.M.B. Medical Applications, Ltd.	HRS	Class II	2011-02-24
K102539	Icuff Repair Plate, Right; Cuff Repair Plate. Left; Anchor Bolt, 10Mm Through 50Mm	Shoulder Options, Inc.	MBI	Class II	2011-02-24
K101797	Sonicision Cordless Ultrasonic Dissection Device Model Scd391, Scd396, Sct12, Scg, Scb, Scsk, Sonicision Sterilization T	Covidien, Formerly Valleylab, A Division of Tyco	LFL	Unclassified	2011-02-24
K101708	Patient Safe Luer Cap	Retractable Technologies, Inc.	FMF	Class II	2011-02-24
K090414	Spectrashield 9500 Surgical Mask	Nexera Medical LLC	ONT	Class II	2011-02-24
K110228	Nidek Multicolor Laser Photocoagulator	Nidek Incorporated	HQB	Class II	2011-02-23
K103825	V-Go Insulin Delivery System	Valeritas, Inc.	LZG	Class II	2011-02-23
K103634	Ascom Clinicalconnex Cardiomax	Ascom (US) Inc.	MSX	Class II	2011-02-23
K103354	Ebony Pta .035 Peripheral Dilatation Catheter	Natec Medical Ltd	LIT	Class II	2011-02-23
K103264	Endoscope Reprocessor Oer-Pro Model Oer-Pro	Olympus Medical Systems Corp.	FEB	Class II	2011-02-23
K103128	Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,	Cadwell Lab, Inc.	ETN	Class II	2011-02-23
K103076	Dynaflex	Dyna Flex	LRK	Class II	2011-02-23
K102971	Freedomaire III Surgical Helmet System Model 10322Stk	Microtek Medical LLC	FYA	Class II	2011-02-23
K102939	Fully Automatic Electronic Blood Pressure Monitor Model Kd-931	Andon Health Co., Ltd	DXN	Class II	2011-02-23
K102769	Neodent Implant for Orthodontic Anchorage	Jjgc Industria E Comercio de Materiais Dentarios S	OAT	Class II	2011-02-23
K102192	Indiscal Digital Manometer	Baylis Medical Co., Inc.	FMF	Class II	2011-02-23
K102125	Patient-Specific Vanguard Femoral Componets	Zimmer GmbH	JWH	Class II	2011-02-23
K101732	Astra Tech Implant System	Astra Tech, Inc.	DZE	Class II	2011-02-23
K100464	Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution	FUJIFILM Healthcare Americas Corporation	NSF	Class II	2011-02-23
DEN110001	Ridascreen Norovirus 3Rd Generation Eia	R-Biopharm AG	OUC	Class II	2011-02-23
K103708	Ml24000 Uva-1 Phototherapy Unit	The Daavlin Distributing Co.	FTC	Class II	2011-02-22
K103445	Alacer Surgical Scaffold	Alacer Biomedical, Inc.	FTL	Class II	2011-02-22
K102270	Envitec Reusable Spo2 Sensors Type Nihon-Kohden	Envitec-Wismar GmbH	DQA	Class II	2011-02-22
K101793	Medihoney Gel Dressing with Active Manuka Honey	Derma Sciences, Inc.	FRO	Unclassified	2011-02-22