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 1556 of 3531

510(k) clearances, page 1556 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012314	Dyonics Electroblade Resector	Smith & Nephew, Inc.	GEI	Class II	2002-02-01
K012241	Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model Cn1001	Cardionet, LLC	DSI	Class II	2002-02-01
K011901	Firstsave Star Biphasic, Model 9210/9200	Survivalink Corp.	MKJ	Class III	2002-02-01
K020077	Modification to Augustine Medical Wound Care System, Model 68Xxx	Augustine Medical, Inc.	MSA	Class I	2002-01-31
K020032	Apex Medical Mini TENS	Apex Medical, Inc.	GZJ	Class II	2002-01-31
K013622	Nucleotomy Intradiscal Catheter	Oratec Interventions, Inc.	GEI	Class II	2002-01-31
K013354	Globalcardio	Cardiocomm Solutions, Inc.	DSH	Class II	2002-01-31
K012985	Matrix Detachable Coils	Boston Scientific Corporation	HCG	Class II	2002-01-31
K012727	Humphrey Oct3	Carl Zeiss Meditec Inc	IYO	Class II	2002-01-31
K020076	Patriot Protrusio Cage	Biomet Orthopedics, Inc.	JDI	Class II	2002-01-30
K020045	3-Piece Proximal Humeral Replacement System	Biomet Orthopedics, Inc.	KWT	Class II	2002-01-30
K020026	Raven Bacterial Spore Strips	Raven Biological Laboratories, Inc.	FRC	Class II	2002-01-30
K014299	Sorba Steorra Non-Invasive Impedance Cardiograph	Sorba Medical Systems, Inc.	DSB	Class II	2002-01-30
K014082	D.sign 53, Model Na1012204	Ivoclar Vivadent, Inc.	EJS	Class II	2002-01-30
K013824	Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V and Z-Tone Preformed Plastic Denture Teeth	Dental Manufacturing SpA	ELM	Class II	2002-01-30
K013820	Finn Chamber (R)	Epitest Ltd. Oy	KXF	Class I	2002-01-30
K013808	Sleepbite	Dental Imagineers, LLC	LRK	Class II	2002-01-30
K013752	Compas as (Computerized Pulmonary Analysis System)	Morgan Scientific, Inc.	BZG	Class II	2002-01-30
K013725	Meditron II Thesterthoscope System	Meditron AS	DQD	Class II	2002-01-30
K013690	Ident-A100 Intraoral Video Camera	Confident Technology, Inc.	EIA	Class I	2002-01-30
K013617	Ltf-240 Pleuravideoscope, Its Accessories and Ancillary Equipments	Olympus Optical Co., Ltd.	GCJ	Class II	2002-01-30
K013196	Ascend Spinal Fixation System with the Shadow Spinal System	Spinal Innovations, LLC	KWP	Class II	2002-01-30
K013167	Model7500 Microcurrent TENS Device, Mct-F5, Mct-F50, Mct-F500	Newcare Products, LLC	GZJ	Class II	2002-01-30
K012924	Datex-Ohmeda Tec 7 Anesthesia Vaporizer	GE Healthcare	CAD	Class II	2002-01-30
K012702	Buechel-Pappas (B-P) Fixed Bearing New Jersey (Nj) Total Knee, Model 1	Endotec, Inc.	JWH	Class II	2002-01-30
K012551	Liverpool Radial Head Replacement Device	Zimmer GmbH	KWI	Class II	2002-01-30
K012184	Blackstone III Anterior Cervical Plating System	Blackstone Medical, Inc.	KWQ	Class II	2002-01-30
K011736	Drg Quickmix	Doctor'S Research Group, Inc.	GXP	Class II	2002-01-30
K011583	Spiked Washer	Synthes (USA) Products LLC	HTN	Class II	2002-01-30
K020171	Coolblu2 Dental Resin Curing Device	Dental Systems.Com, Inc.	EBZ	Class II	2002-01-29
K020012	Modification to Renegade Fiber Braided Microcatheter	Boston Scientific/Medi-Tech	DQO	Class II	2002-01-29
K014245	Jetsonic 2000	Deldent, Ltd.	KOJ	Class II	2002-01-29
K013959	Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers	Bayer Diagnostics Corp.	DKB	Class II	2002-01-29
K013859	Rhodia Bite Registration Material	Rhodia, Inc.	ELW	Class II	2002-01-29
K013665	Pyramid Anterior Plate Fixation System	Medtronic Sofamor Danek	KWQ	Class II	2002-01-29
K013641	Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,connector Cords and Footswitch), Vacuums	Senorx, Inc.	GEI	Class II	2002-01-29
K013639	Thermage Thermacool Tc System	Solta Medical, Inc.	GEI	Class II	2002-01-29
K012576	Cic-C1q Eia	American Laboratory Products Company	DAK	Class II	2002-01-29
K012554	Remstar Auto CPAP System	Respironics, Inc.	BZD	Class II	2002-01-29
K012349	Metavision Clinical Information System	Imdsoft, Ltd.	MWI	Class II	2002-01-29
K011950	Seednet, Model Fp6t5, Fp5t5, Fp5t3	Galil Medical Ltd.	GEH	Class II	2002-01-29
K010790	Cortisol Lia	Kmi Diagnostics, Inc.	CGR	Class II	2002-01-29
K020140	Voxar's Calcium Scoring Product	Voxar Limited	LLZ	Class II	2002-01-28
K014103	Synchron Systems Direct Ldl Chloesterol Reagent and Calibrator	Siemens Healthcare Diagnostics Inc.	MRR	Class I	2002-01-28
K014055	Non-Sterile Powdered Latex Examination Gloves with a Protein Claim on Labeling	Seal Polymer Industries Bhd.	LYY	Class I	2002-01-28
K014021	Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed	Surgical Specialties Corp	GAM	Class II	2002-01-28
K014012	Doc Band	Cranial Technologies, Inc.	OAN	Class II	2002-01-28
K013983	Wiener Lab. Alp 405	Wiener Laboratories Saic	CJE	Class II	2002-01-28
K013938	Irma Sl Blood Analysis System Lactate Cartridge	Diametrics Medical, Inc.	KHP	Class I	2002-01-28
K013927	Mini Shopper	Shoprider Intl., Inc.	INI	Class II	2002-01-28