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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 426 of 3528

510(k) clearances, page 426 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192523	CMOS Video Esophagoscope SSU	Karl Storz SE & Co. KG	EOX	Class II	2020-01-24
K192493	BD Cathena (TM) Safety IV Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2020-01-24
K192333	Blue Nitrile Examination Gloves Powder Free	JR Engineering and Medical Technologies (M) Sdn Bhd	LZA	Class I	2020-01-24
K192014	SYPMHONY™ OCT System	Medos International SARL	NKG	Class II	2020-01-24
K191432	cortiQ PRO	G.tec Medical Engineering GmbH	OLU	Class II	2020-01-24
K191406	KardiaMobile, KardiaStation	AliveCor	DXH	Class II	2020-01-24
K191293	LCCS VC-S RF Cannula	Lccs Products Limited	GXI	Class II	2020-01-24
K191249	Carescape B450	GE Healthcare Finland Oy	MHX	Class II	2020-01-24
K191227	Paratrooper Plantar Plate Repair System	Paragon 28	MBI	Class II	2020-01-24
K191144	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2020-01-24
K193504	HardyDisk AST Cefiderocol 30ug (FDC30)	Hardy Diagnostics	JTN	Class II	2020-01-23
K193295	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	Parcus Medical, L.L.C.	MBI	Class II	2020-01-23
K192530	Surefil one Self-adhesive Composite Hybrid	Dentsply Sirona Inc	EMA	Class II	2020-01-23
K192436	Healing Abutments and Cover Screws	Dentium Co., Ltd.	NHA	Class II	2020-01-23
K192349	Bactisure Wound Lavage	Next Science, LLC	FQH	Class II	2020-01-23
K192330	EEA Circular Stapler with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2020-01-23
K192170	VistaScan USB Ultrasound Imaging System	Emagine Solutions Technology, LLC	IYO	Class II	2020-01-23
K192092	Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535	Seca GmbH & Co. KG	DXN	Class II	2020-01-23
K192025	STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader	Advanced Sterilization Products (Asp)	FRC	Class II	2020-01-23
K191821	Blue Phantom PT	IBA Dosimetry GmbH	LHN	Class II	2020-01-23
K191270	Proneb Max	Pari Respiratory Equipment, Inc.	CAF	Class II	2020-01-23
K191014	Elements Viewer	Brainlab, Inc.	LLZ	Class II	2020-01-23
K190839	GammaTile	GT Medical Technologies	KXK	Class II	2020-01-23
K190271	FiteBac Cavity Cleanser	Largent Health, LLC	LBH	Class II	2020-01-23
K190120	Vinno 8, Vinno 6, Vinno 5	Vinno Technology (Suzhou) Co.,Ltd	IYN	Class II	2020-01-23
K193606	Y-Knot OneStep Anchor	ConMed Corporation	MBI	Class II	2020-01-22
K193574	Q-Rad System	Eastman Kodak Company	KPR	Class II	2020-01-22
K192993	Scarlet Al-T	Spineart SA	OVD	Class II	2020-01-22
K192684	HydroPearl Microspheres	Terumo Cardiovascular Systems Corporation	NOY	Class II	2020-01-22
K192502	Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus	Medtronic Sofamor Danek USA Inc	MAX	Class II	2020-01-22
K192161	FastFit EMS System	Fast Fit, LLC	NGX	Class II	2020-01-22
K191322	E-Eegx, N-Eegx	GE Healthcare Finland Oy	OLT	Class II	2020-01-22
K191109	Spectra Q	Uzinmedicare Co., Ltd.	HGX	Class II	2020-01-22
K191093	Isopure Dry Acid Dissolution System	Isopure Corp	KPO	Class II	2020-01-22
K190954	Fundus Camera	Chongqing Bio Newvision Medical Equipment Ltd.	HKI	Class II	2020-01-22
K190837	Internal Hex Implant System	Ebi, Inc.	DZE	Class II	2020-01-22
K193569	Pivo(tm)	Becton Dickinson Infusion Therapy Systems Inc.	JKA	Class II	2020-01-21
K193566	ZELTIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2020-01-21
K193370	Nexxt Matrixx System	Nexxt Spine LLC	MAX	Class II	2020-01-21
K192985	Medline Glide-On 3G Vinyl Examination Gloves	MEDLINE INDUSTRIES, LP - Northfield	LYZ	Class I	2020-01-21
K192564	Disposable Gold Cup EEG Electrodes	Dymedix Diagnostics Inc	GXY	Class II	2020-01-21
K191425	Hydro-Temp Neonatal Skin Temperature Probe Cover	DeRoyal Industries, Inc.	FMT	Class II	2020-01-21
K191229	TrapIt	IMDS Operations B.V.	DQY	Class II	2020-01-21
K191149	Carescape B650	GE Healthcare Finland Oy	MHX	Class II	2020-01-21
K193222	Tyber Medical Anatomical Plating System	Tyber Medical	HRS	Class II	2020-01-20
K192098	EzMobile	Ewoosoft Co., Ltd	LLZ	Class II	2020-01-20
K193548	Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	DQX	Class II	2020-01-18
K193045	geko™ W-2	Firstkind Ltd	IPF	Class II	2020-01-18
K193590	CareSens S Fit BT Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2020-01-17
K193570	Dental Pain Eraser	Synapse Dental	LWM	Unclassified	2020-01-17