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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 499 of 3529

510(k) clearances, page 499 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182127	Wrist Blood Pressure Monitor Model BP6100	Omron Healthcare Co., Ltd.	DXN	Class II	2018-11-02
K182121	CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition	Medtronic Sofamor Danek USA Inc	OLO	Class II	2018-11-02
K182110	CDI Blood Parameter Monitoring System 550	Terumo Cardiovascular Systems Corporation	DRY	Class II	2018-11-02
K182104	NavLock Trackers, Robotic Reference Frame	Medtronic Navigation, Inc	OLO	Class II	2018-11-02
K182096	Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs	Owens & Minor Halyard, Inc.	LZA	Class I	2018-11-02
K182077	Mazor X System (Mazor X Stealth Edition)	Mazor Robotics Ltd	OLO	Class II	2018-11-02
K181911	Interlude 100% Cotton Tampon	Albaad Fem	HEB	Class II	2018-11-02
K181837	Spinal Elements Ti-Bond coated devices	Spinal Elements, Inc	MAX	Class II	2018-11-02
K181639	Panta 2 Arthrodesis Nail System	Integra LifeSciences Corporation	HSB	Class II	2018-11-02
K181501	Afina	Neurovision Imaging, Inc.	NFJ	Class II	2018-11-02
K181403	Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR	GE Healthcare	OWB	Class II	2018-11-02
K181208	Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter	Vygon U.S.A.	PND	Class II	2018-11-02
K181195	ClearPoint System	Mri Interventions, Inc.	ORR	Class II	2018-11-02
K180786	Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff	Hartalega Sdn Bhd	LZA	Class I	2018-11-02
K180601	Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)	Villa Sistemi Medicali S.p.A.	OAS	Class II	2018-11-02
K180415	Invia White Foam NPWT	Medela AG	OMP	Class II	2018-11-02
K180253	Sheridan Endobronchial Tubes	Teleflex Medical	CBI	Class II	2018-11-02
K180180	HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)	M.I.Tech Co Ltd	MQR	Class II	2018-11-02
DEN170092	Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System	Fluoptics	QDG	Class II	2018-11-02
DEN170056	Parathyroid Detection (Model PTeye) System	Aibiomed, Corp.	QDF	Class II	2018-11-02
K182523	Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens	Largan Medical Co., Ltd.	LPL	Class II	2018-11-01
K182276	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit	Medrad, Inc.	DXT	Class II	2018-11-01
K182273	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT	Medrad, Inc.	DXT	Class II	2018-11-01
K182098	N Latex FLC kappa assay, N Latex FLC lambda assay	Siemens Healthcare Diagnostics Products Limited	DFH	Class II	2018-11-01
K181820	Medline Unite Mini Plates and Screws	MEDLINE INDUSTRIES, LP - Northfield	HRS	Class II	2018-11-01
K181273	GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2018-11-01
K181266	Implantswiss Dental Implant System, Implantswiss Dental Abutment System	Novodent SA	DZE	Class II	2018-11-01
K181049	Spectra Optia Apheresis System	Terumobct, Inc.	LKN	Unclassified	2018-11-01
K180363	Clear-Tip EUS-FNA	Finemedix	FCG	Class II	2018-11-01
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc.	HRS	Class II	2018-11-01
K180247	DAEHAN Adhesive Surface Electrodes	Daehan Medical Systems Co.,Ltd	GXY	Class II	2018-11-01
K182880	Halifax Imaging Kit	Halifax Biomedical Inc.	KPR	Class II	2018-10-31
K182679	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1	Canon Medical Systems Corporation	IYN	Class II	2018-10-31
K182588	Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	NUJ	Class II	2018-10-31
K182088	XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro	Fotona d.o.o.	GEX	Class II	2018-10-31
K182087	DynaMesh-POSTERIOR	Feg Textiltechnik Forschungs- und Entwicklungsgesellschaft	FTL	Class II	2018-10-31
K182085	Balanced Knee Revision System Trabecular Tibial Cone Augments	Ortho Development Corp.	JWH	Class II	2018-10-31
K182082	Tumark for Eviva, Tumark for Brevera	SOMATEX Medical Technologies GmbH	NEU	Class II	2018-10-31
K181994	Single Use Aspiration Needle NA-U201H	Olympus Medical Systems Corp.	FCG	Class II	2018-10-31
K181553	Immunalysis Ethyl Alcohol Enzyme Assay	Immunalysis Corporation	DIC	Class II	2018-10-31
K180899	Universal Base Abutment	Nobel Biocare AB	NHA	Class II	2018-10-31
K180735	Endomat Select	Karl Storz SE & Co. KG	HIG	Class II	2018-10-31
K173351	Panpac Flexi Shelf Pessary	Panpac Medical Corporation	HHW	Class II	2018-10-31
K171585	LUXEN Zr, LUXEN Smile	Dentalmax Co., Ltd	EIH	Class II	2018-10-31
K171199	Aview	Coreline Soft Co., Ltd.	LLZ	Class II	2018-10-31
DEN180028	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports	23AndMe, Inc.	QDJ	Class II	2018-10-31
K182540	DiLumen Endolumenal Interventional Platform	Lumendi, LLC	FDF	Class II	2018-10-30
K182466	AOS Calcaneal Plating System	Advanced Orthopaedic Solutions, Inc.	HRS	Class II	2018-10-30
K182392	Frozen C	B.M. Tech. Worldwide Co., Ltd.	GEH	Class II	2018-10-30
K182381	Wilson-Cook Mini Basket	Wilson-Cook Medical Inc.	LQR	Class II	2018-10-30