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 1503 of 3531

510(k) clearances, page 1503 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023314	Microfix	Fixano SA	KTT	Class II	2002-10-18
K023260	1.2Mm Osteomed Auto-Drive Screw System	Osteomed	HWC	Class II	2002-10-18
K023249	Alcon Ladarwave Customcornea Wavefront System	Alcon Laboratories	NCF	Class I	2002-10-18
K023235	Multiple Private Labels Vinyl Examination Gloves, Powder-Free	Shandong Jiazhan Plastic Products Co., Ltd.	LYZ	Class I	2002-10-18
K023204	Modification to Ebi Omega21 Spinal Fixation System	Ebi, LLC	MNH	Class II	2002-10-18
K023133	Modification to Ebi Vuelock Anterior Cervical Plate System	Ebi, LLC	KWQ	Class II	2002-10-18
K023116	Cordis Optease Permanent Vena Cava Filter, Models 466-F200a, 466-F200b	Cordis US Corp.	DTK	Class II	2002-10-18
K023099	Arox 45-Jbp; Arox 53-Jbp; Merox 45-Jbp; Merox 53-Jbp	BIOTRONIK AG	DTB	Class III	2002-10-18
K023092	Bd K-4000 Microkeratome System	Becton Dickinson & Co	HMY	Class I	2002-10-18
K023069	Timex Digital Oral Thermometers; Timex Accucurve Oral Thermometer	Medport, Inc.	FLL	Class II	2002-10-18
K023005	Aquilla Modular Wheelchair	Haywood Vocational Opportunities Inc.	IOR	Class I	2002-10-18
K022969	Universal Ceramic Solder	Ivoclar Vivadent, Inc.	EJT	Class II	2002-10-18
K022895	Elcam Stopcocks and Manifolds	Medical Device Consultants, Inc.	FMG	Class II	2002-10-18
K022862	Transcure, Model 2910	Kinetic Instruments, Inc.	EBZ	Class II	2002-10-18
K022756	Nipro Bio-Flex Catheter	Nipro Medical Corporation	FOZ	Class II	2002-10-18
K022430	ISO Functional	GC America Inc.	ELW	Class II	2002-10-18
K022384	Xenon Fiberoptic Light Source, Model 1300 Xsbp	Isolux America	HET	Class II	2002-10-18
K022381	Profile 1320 Laser System	Sciton, Inc.	GEX	Class II	2002-10-18
K022378	Plasmalite Pulsed Light System	Medical Bio Care Sweden AB	GEX	Class II	2002-10-18
K022370	Framelock; Framelock Accessories	Medtronic Xomed, Inc.	HBG	Class II	2002-10-18
K022346	Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro Copolymer Examination Gloves	Latexx Manufacturing Sdn.Bhd.	LZA	Class I	2002-10-18
K022204	Vks Knee System	Plus Orthopedics	JWH	Class II	2002-10-18
K022043	Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503	Medennium, Inc.	LZU	Unclassified	2002-10-18
K021688	Nicalert	Nymox Pharmaceutical Corporation	MRS	Class I	2002-10-18
K021451	Duracon Cs Tibial Insert	Howmedica Osteonics Corp	JWH	Class II	2002-10-18
K021200	Compas	Morgan Scientific, Inc.	BZG	Class II	2002-10-18
K023291	Cobra Cooled Cardiac Surgical Probe, Model 1596X	Boston Scientific Corporation	GEI	Class II	2002-10-17
K023270	Sas Strepalert	SA Scientific, Ltd	GTY	Class I	2002-10-17
K023250	Linical Protein 2 Calibration Verifiers Levels a-E for the Beckman-Coulter Immage	Cliniqa Corporation	JJY	Class I	2002-10-17
K023211	Nexgen Complete Knee Solution Cruciate Retaining (Cr)-Flex Femoral Components	Zimmer GmbH	JWH	Class II	2002-10-17
K023203	Osstaple	Biomedical Ent., Inc.	JDR	Class II	2002-10-17
K023186	Optetrak Total Knee System Offset Tibial Tray	Exactech, Inc.	JWH	Class II	2002-10-17
K023085	Rx 90 Femoral Stem and Rx 90 Lateralized Femoral Stem	Biomet Orthopedics, Inc.	JDI	Class II	2002-10-17
K022924	Sherpa Mobility System (Manual Wheelchair)	Otto Back Healthcare, LP	IOR	Class I	2002-10-17
K022824	Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, Lv Analysis 1.X & Surgical View 1.X	TOMTEC Imaging Systems GmbH	LLZ	Class II	2002-10-17
K022670	Carraklenz and Ultraklenz	Carrington Laboratories, Inc.	FRO	Unclassified	2002-10-17
K022651	Hoffmann 30 Degree Pelvic Double Ball Joint	Howmedica Osteonics Corp	LXT	Class II	2002-10-17
K022595	Wilson-Cook Cystotome	Wilson-Cook Medical Inc.	KNS	Class II	2002-10-17
K022403	Gmrs Press Fit Stems with Purefix Ha	Howmedica Osteonics Corp	LZO	Class II	2002-10-17
K021856	Porges Ureteral Catheters, Models Acn6xx, Acn5xx, Ac5b, Ac5c07, Acp5xx, Acp2xx, Acp3xx, Acp4xx, Acp6xx	Porges Corp.	EYB	Class II	2002-10-17
K021835	Brennen Medical Surgical Mesh, Glucamesh/glucatex	Brennen Medical, Inc.	FTL	Class II	2002-10-17
K021815	Smith & Nephew Image Surgical Instruments for Trauma Applications	Smith & Nephew, Inc.	HAW	Class II	2002-10-17
K021351	Biosteon Cross Pin	Biocomposites, Ltd.	HWC	Class II	2002-10-17
K013921	Porges Silicone Double Loop Ureteral Stent, Model # Aj4x / Bj1x / Bj2x	Porges Corp.	FAD	Class II	2002-10-17
K012816	Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414	Dynarex Corp.	FRO	Unclassified	2002-10-17
K023376	Eb-1830T3, Video Bronchoscope	Pentax Precision Instrument Corp.	EOQ	Class II	2002-10-16
K023136	Oleeva Fabric	Bio Med Sciences, Inc.	MDA	Class I	2002-10-16
K023065	Cyclosporine (Csa) Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	MKW	Class II	2002-10-16
K022754	S&t Single Use Micro Anastomosis Clamp	S & T AG	DXC	Class II	2002-10-16
K022637	Bd-3000 Microkeratome System, Model K-3000 Microkeratome	Becton Dickinson & Co	HMY	Class I	2002-10-16