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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 850 of 3530

510(k) clearances, page 850 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123780	Transtek Blood Pressure Monitor	Zhongshan Transtek Electronics Co., Ltd	DXN	Class II	2013-03-01
K123761	Vita Enamic Stains	Innovation Meditech GmbH	EBD	Class II	2013-03-01
K123749	Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	2013-03-01
K123675	Re-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 Cm, Ureteral Access Sheath, 12/14 Ch-Fr, Length 35Cm, Ur	MEDLINE INDUSTRIES, LP - Northfield	FED	Class II	2013-03-01
K123606	Cassi II Rotational Core Biopsy System; Cassi Quadpoint Disposable	Scion Medical Technologies, LLC	KNW	Class II	2013-03-01
K123602	Tm Ardis Interbody System Inserter	Zimmer Trabecular Metal Technology, Inc.	MAX	Class II	2013-03-01
K123426	Medicvod, Medicast, Medishow, Medisearch, Central Storage System - Css	Orpheus Medical, Ltd.	LLZ	Class II	2013-03-01
K123365	Olympus Ltf-190-10-3D, Maj-Y0154, Olympus Cv-190	Olympus Medical Systems Corp.	HET	Class II	2013-03-01
K123220	Vertex Thermosens Rigid	Vertex-Dental B.V.	EBI	Class II	2013-03-01
K122955	Dentavit, Monarch, Acrotone, Senator, Dentorium	Wright Health Group	ELM	Class II	2013-03-01
K122590	Radifocus Glidewire Advantage, Radifocus Glidewire Advantage	Terumo Medical Corp.	DQX	Class II	2013-03-01
K122016	Rextar, Rextar Lcd	Meta Biomed Co., Ltd.	EHD	Class II	2013-03-01
K121430	Evolution Biliary Stent System	Cook Ireland Ltd.	FGE	Class II	2013-03-01
K120001	Unigold Giardia	Trinity Biotech, PLC	MHI	Class II	2013-03-01
K130131	Edrain Chest Drainage System	Atrium Medical Corporation	BTA	Class II	2013-02-28
K130078	Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. dba Angiotech	GAW	Class II	2013-02-28
K123965	Cobas Integra Bilirubin Direct Gen.2	Roche Diagnostics GmbH	CIG	Class II	2013-02-28
K123959	Circuflow 5150	Devon Medical, Inc.	JOW	Class II	2013-02-28
K123869	Powder-Free Nitrile Patient Examination Gloves	Dehai (Shandong) Medical Gloves, Co., Ltd.	LZA	Class I	2013-02-28
K123751	Lofric Sense	Wellspect Healthcare	EZD	Class II	2013-02-28
K123738	Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite Std	Nidek Medical Products Inc	CAW	Class II	2013-02-28
K123707	Alight 16 Superselective Microwire Guide	Cook Inc.	DQX	Class II	2013-02-28
K123679	3M Tegaderm Chg Chlorhexidine Gluconate i.v. Port Dressing	3M Company	FRO	Unclassified	2013-02-28
K123497	Facet Screw System	Facet-Link, Inc.	MRW	Unclassified	2013-02-28
K123348	Clear Aligner Adhesive	Reliance Orthodontic Products, Inc.	DYH	Class II	2013-02-28
K123289	Durablue Sterilization Wrap	Medtronic, Inc.	FRG	Class II	2013-02-28
K123195	Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories	GE Healthcare Finland Oy	CCL	Class II	2013-02-28
K122936	Ankle Trauma System	Orthopro, LLC	HRS	Class II	2013-02-28
K122872	Intervertebral Body Fusion Device	Dio Medical Co., Ltd.	ODP	Class II	2013-02-28
K122647	Synthes Patient Specific Plate	Synthes GmbH	JEY	Class II	2013-02-28
K121999	General Purpose Temperature Probe, Skin Temperature Probe	Draeger, Inc.	FLL	Class II	2013-02-28
K121969	U-Right Compressor Nebulizer	Taidoc Technology Corporation	CAF	Class II	2013-02-28
K121901	Ti-Max Z45	Nakanishi Inc.	EGS	Class I	2013-02-28
K130197	Bd Phaseal Closed System Transfer Device - P55	Becton Dickinson & Co	ONB	Class II	2013-02-27
K130196	Speedlock Knotless Fixation Device, 3Mm Drill, 3Mm+ Drill, Pathfinder Obturator & Sharp Tipped Obturator, Low Profile Dr	ArthroCare Corporation	MBI	Class II	2013-02-27
K130092	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	OUR	Class II	2013-02-27
K130061	Piccolo Composite Plate System	CarboFix Orthopedics Inc.	HRS	Class II	2013-02-27
K123979	Quattro Air	ResMed Corp	BZD	Class II	2013-02-27
K123816	Digital Electrocardiographs	Shenzhen Biocare Electronics Co., Ltd.	DPS	Class II	2013-02-27
K123682	Inmode Hair Removal (Hr) Device	Inmode MD, Ltd.	GEX	Class II	2013-02-27
K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)	Inion Oy	HWC	Class II	2013-02-27
K123501	Oss Modular Stems, Oss Diaphyseal Segments	Zimmer GmbH	JDI	Class II	2013-02-27
K123442	Xoft Axxent Cervical Applicators	iCAD, Inc.	JAQ	Class II	2013-02-27
K123361	Esotest Esophageal Temperature Probe and Temperature Monitoring System	Fiab SpA	FLL	Class II	2013-02-27
K123002	Vital Sync System	Covidien, Formerly Nellcor Puritan Bennett, Inc.	MWI	Class II	2013-02-27
K122661	Vital 5 Releaf Catheter	Vital 5	BSO	Class II	2013-02-27
K121360	Biodesign ENT Repair Graft	Cook Biotech Incorprated	KHJ	Class II	2013-02-27
K120592	Dana Reusable Bowie Test Pack for Dana Bowie Dick Indicators	Dana Products, Inc.	JOJ	Class II	2013-02-27
K124052	Ostavi Hydrophilic Guidewire	Lake Region Medical	OCY	Class II	2013-02-26
K123668	Orthocord	DePuy Mitek, Inc.	NEW	Class II	2013-02-26