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 1504 of 3531

510(k) clearances, page 1504 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022357	Transend 300 Es Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815	Boston Scientific Corporation	DQX	Class II	2002-10-16
K022351	Diodent Dental Laser System	Continuum Electro-Optics, Inc.	GEX	Class II	2002-10-16
K022338	Optical Integrity General Shaped Fiber	Optical Integrity, Inc.	GEX	Class II	2002-10-16
K022327	Novus Spectra	Lumenis Ltd	GEX	Class II	2002-10-16
K021936	Moist Punctal Plug System	Moist Medical, Inc.	LZU	Unclassified	2002-10-16
K021889	Surgiform Augmentation Material (S.f.a.m.)	Surgical Technology Laboratories Inc.	KKY	Class II	2002-10-16
K020054	Sanarus Indica Marker System	Sanarus Medical, Inc.	FZP	Class II	2002-10-16
K022668	Advia 120 Hematology System Complete Blood Count (Cbc) Method	Bayer Diagnostics Corp.	GKZ	Class II	2002-10-15
K022566	Powder-Free Latex Examination Glove (Green) with Natural Water Soluble Vitamin E and Protein Content Labeling (50 Micro	Qingdao Bestex Rubber & Plastic Products Co., Ltd	LYY	Class I	2002-10-15
K022314	Sanarus Visica Treatment System	Sanarus Medical, Inc.	GEH	Class II	2002-10-15
K022016	Polymer Coated Powderfree Latex Examination Glove	Top Glove Medical (Thailand) Co., Ltd.	LYY	Class I	2002-10-15
K023221	Contact Laser & Diagnostic Lenses	Volk Optical Inc	HJK	Class II	2002-10-11
K023164	Bbc-63-Ge Breast Array Coil	Mri Devices Corp.	MOS	Class II	2002-10-11
K023145	Vinyl Examination Gloves, Pre-Powdered	Shandong Jiazhan Plastic Products Co., Ltd.	LYZ	Class I	2002-10-11
K023130	Eloquence, Integrated Functional Imaging System	Mri Devices Corp.	LNH	Class II	2002-10-11
K023100	Accusketch Cardiac Quantitative System W/ Advanced Analysis Components	General Electric Medical Systems Information Techn	LLZ	Class II	2002-10-11
K023061	Konica Direct Digitizer Regius, Model 170	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2002-10-11
K023052	Acuity Radiation Therapy Simulator	Varian Medical Systems, Inc.	KPQ	Class II	2002-10-11
K022940	In-Vision View with Measurements Module, Model 1.0	Intelligent Images SRL	LLZ	Class II	2002-10-11
K022897	Modification to Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	2002-10-11
K022810	Cobrascan Cr-1 Filmless	Radiographic Digital Imaging, Inc.	LMA	Class II	2002-10-11
K022794	E-Speed Ebt Scanner System	GE Imatron	JAK	Class II	2002-10-11
K022765	Nitrile Powder-Free Examination Gloves	Medtronic, Inc.	LZA	Class I	2002-10-11
K022757	Spife Ck Kit, Model 3332, 3333	Helena Laboratories, Corp.	JHY	Class II	2002-10-11
K022728	Audiotraveller, Model Aa222	Interacoustics A/S, Assens	ETY	Class II	2002-10-11
K022716	Med-Logics Microkeratome Blade, Model 7020Clb	Med-logics Inc	HNO	Class I	2002-10-11
K022710	Smartpacs	Taiwan Electronic Data Processing Corporation	LLZ	Class II	2002-10-11
K022692	Voxelplus Pacs	Mevisys Co., Ltd.	LLZ	Class II	2002-10-11
K022620	Sheathless Accessory Kit, Models Xrik24, Xrik28, Xrik32, Xrik36, Xrik40 and Xrikrt	Spire Biomedical, Inc.	FKA	Class II	2002-10-11
K022585	Kimax Qma	Medical Metrics, Inc.	LLZ	Class II	2002-10-11
K022562	Various Branemark System Implants-Immediate Function Indication	Nobel Biocare AB	DZE	Class II	2002-10-11
K022545	Glucobalance Data Management Software, Model 555020	Arkray Factory USA, Inc.	NBW	Class II	2002-10-11
K022493	Ems 400	Body Clock Health Care Ltd	IPF	Class II	2002-10-11
K022492	Pulpdent Semi-Gel Etch	Pulpdent Corporation	EBF	Class II	2002-10-11
K022415	Bone Injection Gun (B.i.g.) for Pediatrics, Model 1St	Waismed Ltd.	FMI	Class II	2002-10-11
K022398	Reusable Bronchial Biopsy Forceps	Ballard Medical Products	BWH	Class II	2002-10-11
K022390	Hitachi Altaire	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2002-10-11
K022369	Comfort Windjoy Scooter, Model Ly-Ew302	Comfort Orthopedic Co., Ltd.	INI	Class II	2002-10-11
K022336	Baldur Brand Vinyl Powdered Examination Gloves, Sun Flower Gloves Co., Ltd	Tangshan Zhonghong Pulin Group Co., Ltd.	LYZ	Class I	2002-10-11
K022286	Encircle Localization Device	Vivant Medical, Inc.	KNW	Class II	2002-10-11
K022280	Stockert Coronary Perfusion Cannulae	Stockert Instrumente GmbH	DWF	Class II	2002-10-11
K022117	Majestik (Tm) Shielded Angiography Needle, Model Stan18t71w-25, Majestik (Tm) Shielded Angiogtaphy Needle, Sran18t71wr-5	Merit Medical Systems, Inc.	DRC	Class II	2002-10-11
K021937	Tgdc-01 Pra	Truevision Instruments	HKX	Class II	2002-10-11
K021910	Comfort Dreamrider Scooter, Ly-Ew402	Comfort Orthopedic Co., Ltd.	INI	Class II	2002-10-11
K021752	Fp(hexafocon A)rgp Contact Lens Spherical/asp(hexafocon A)rgp Contact Lens Aspherical	Lucid Korea Co., Ltd.	HQD	Class II	2002-10-11
K021446	Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir	Oemedic International, Inc.	BTM	Class II	2002-10-11
K021087	Hippocrat Electronic Stethoscope, Model Dr300; Sounds Easy Auscultation Software	Erecords Limited	DQD	Class II	2002-10-11
K020964	Neich Nm Advance Catheter Sheath Introducer	Neich Medical (Shenzhen) Company Limited	DYB	Class II	2002-10-11
K020936	10F X 18Cm Pediatric Ash Split Cath Xl, Model Aspc18p-Xl; 10F X 24Cm Pediatric Ash Split-Cath Xl, Model Aspc24p-Xl	Medcomp	MSD	Class II	2002-10-11
K020839	Quantum, Models Sr, Hr, Dl; Vasculight, Models Sr, Hr, Vs, Vx, Dl	Lumenis Ltd	GEX	Class II	2002-10-11