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 492 of 3529

510(k) clearances, page 492 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182954	Salvo™ Spine System	Spine Wave Inc	NKB	Class II	2018-12-12
K182812	Medline Cautery Electrode (SILICONE)	MEDLINE INDUSTRIES, LP - Northfield	GEI	Class II	2018-12-12
K182473	PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems	K2M, Inc	KWQ	Class II	2018-12-12
K182339	LEUCADIA AUTOLOK™ Pedicle Screw System	Clearview Orthopedic Development, LLC	NKB	Class II	2018-12-12
K181869	On1 Universal Abutment	Nobel Biocare AB	NHA	Class II	2018-12-12
K180578	Harvest Dental Polymer Blocks	Harvest Dental Products LLC	EBG	Class II	2018-12-12
DEN170055	Retrograde Intubation Set	Cook Incorporated	QCX	Class II	2018-12-12
K183307	Magma Spark Pro (Magma Spark Plus, Alpha)	Formatk Systems Ltd.	GEX	Class II	2018-12-11
K183168	OpenLoc-L Spinal Fixation System	L&K Biomed Co.,Ltd.	NKB	Class II	2018-12-11
K183107	Intuitive Surgical Vessel Sealer Extend	Intuitive Surgical, Inc.	NAY	Class II	2018-12-11
K182946	Invacare TDX SP2-HD with Captain's Seat	Invacare GmbH	ITI	Class II	2018-12-11
K182902	Precision1	Alcon Laboratories	LPL	Class II	2018-12-11
K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	CooperVision, Inc.	LPL	Class II	2018-12-11
K181744	BI-MENTUM dual mobility system	Serf	LZO	Class II	2018-12-11
K181625	Life Spine Resolute™ Threaded Cage System	Life Spine	MAX	Class II	2018-12-11
K181174	Cardinal Health Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2018-12-11
K180999	Mygen V-1000 RF System	RF Medical Co., Ltd	GEI	Class II	2018-12-11
K183080	Mega Plus Spine System	BK Meditech Co., Ltd.	NKB	Class II	2018-12-10
K182831	SabreLine and SabreGuard Laser Fibers	MEDLINE INDUSTRIES, LP - Northfield	GEX	Class II	2018-12-10
K182810	Distal Radius Plating System	Miami Device Solutions, LLC	HRS	Class II	2018-12-10
K182724	CelerityTM 10 STEAM Chemical Indicator	STERIS Corporation	JOJ	Class II	2018-12-10
K182584	Lucent® XP	Spinal Elements, Inc	MAX	Class II	2018-12-10
K182512	Route 92 Medical Delivery Catheter	Route 92 Medical, Head Quarters	DQY	Class II	2018-12-10
K182506	LipiScan Dynamic Meibomian Imager	TearScience, Inc.	HKI	Class II	2018-12-10
K182491	Applanation tonometer AT-2	Takagi Seiko Co., Ltd.	HKY	Class II	2018-12-10
K182280	ARK Tramadol Assay	Ark Diagnostics Inc	DJG	Class II	2018-12-10
K182075	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2018-12-10
K182038	URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer	YD Diagnostics	JFY	Class II	2018-12-10
K181967	Disposable Temperature Probe	Shenzhen Launch Electrical Co., Ltd	FLL	Class II	2018-12-10
K181826	Glenoid Polyaxial Non-locking Screws	Medacta International SA	PHX	Class II	2018-12-10
K181766	VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance	bioMerieux, Inc.	LON	Class II	2018-12-10
K181675	FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System	Taidoc Technology Corporation	PTC	Class I	2018-12-10
K181498	X-ray Imaging System for the McLaren Proton Treatment System	Ehmetdx, LLC	LHN	Class II	2018-12-10
K181405	Hailie Sensor	Adherium (Nz), Ltd.	CAF	Class II	2018-12-10
K180945	LUTRONIC GENIUS Radiofrequency System	Lutronic Corporation	GEI	Class II	2018-12-10
K180831	CATSmart	Fresenius Kabi AB	CAC	Class II	2018-12-10
K180533	Procellera Composite Antibacterial Wound Dressing	Vomaris Wound Care, Inc.	FRO	Unclassified	2018-12-10
K173681	reSET-O	Pear Therapeutics, Inc.	PWE	Class II	2018-12-10
K183286	17Hk701g-W	LG Electronics.Inc	MQB	Class II	2018-12-07
K183212	Nexus DR Digital X-ray Imaging System with stitching	Varex Imaging Corporation	MQB	Class II	2018-12-07
K183111	Contour 24	Quality Electrodynamics	MOS	Class II	2018-12-07
K183102	BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody	Leica Biosystems Newcastle Ltd.	MXZ	Class II	2018-12-07
K183100	Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra	Leica Biosystems Newcastle Ltd.	MYA	Class II	2018-12-07
K182809	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	LFL	Unclassified	2018-12-07
K182664	FiXcision	Agency for Medical Innovations Inc.	KOA	Class I	2018-12-07
K182183	Gc70, Gu60a, Gu60a-65, Gf50, Gr50a ; Gr40cw ; Gm85 ; Gc85a	Samsung Electronics Co., Ltd.	KPR	Class II	2018-12-07
K182048	Avenir Complete Hip System	Zimmer GmbH	LZO	Class II	2018-12-07
K182007	Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System	Renovis Surgical Technologies, LLC	OVD	Class II	2018-12-07
K181695	Nihon Kohden NKV-550 Series Ventilator System	Nihon Kohden Orangemed, LLC	CBK	Class II	2018-12-07
K181583	Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20	Flexicare Medical Ltd.	BTM	Class II	2018-12-07