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 1917 of 3531

510(k) clearances, page 1917 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970372	Gastroscope and Colonoscope Nozzle Replacement Kits	Precision Endoscopy of America, Inc.	FDF	Class II	1997-03-11
K970313	Prepowdered Latex Examination Glove	Besglove Healthcare Sdn. Bhd.	LYY	Class I	1997-03-11
K970256	Intraoral Mandibular Distraction Device	Medicon, E.G.	JEY	Class II	1997-03-11
K970240	Diffuser Panel	Focused Viewer, Inc.	IXC	Class I	1997-03-11
K970079	Proximate Disposable Skin Stapler	Ethicon Endo-Surgery Inc	GAG	Class II	1997-03-11
K970063	Series 7600 Mobile Digital C-Arm	GE Dec Medical Systems	OWB	Class II	1997-03-11
K965211	Vista Brite Tip Catheters	Cordis US Corp.	DQY	Class II	1997-03-11
K965170	Roccobarocco & Pro-Dynamix	Michelangelo, Inc.	HQY	Class I	1997-03-11
K965107	Medline Admission Kits	MEDLINE INDUSTRIES, LP - Northfield	FXX	Class II	1997-03-11
K965082	Soothing Water-Filled Teether	Consolidated Stores Corp.	KKO	Class II	1997-03-11
K965058	Nichols Advantage Chemiluminescence Free T3 Kit	Nichols Institute Diagnostics	CDP	Class II	1997-03-11
K965012	Lifestyle Break Thru (Polymacon)	The Lifestyle Co., Inc.	LPL	Class II	1997-03-11
K965004	C.a.r.e. Vision for the Somatom Plus 4 CT Scanner	Siemens Medical Solutions USA, Inc.	JAK	Class II	1997-03-11
K964979	Porous Media Dbf23 Disposable Respiratory Filter	Pentair Filtration Solutions	CAH	Class II	1997-03-11
K964902	Contact Lenses Metro-G 3X (Hioxifilcon B)	Metro Optics of Austin, Inc.	LPL	Class II	1997-03-11
K964636	Force Argon II Argon Enhanced Electrosurgical System	Medtronic, Inc.	GEI	Class II	1997-03-11
K964474	Ultrafree Sterile Latex Powder-Free Surgical Gloves	Medtronic, Inc.	KGO	Class I	1997-03-11
K964342	Cytoplast Gbr	Osteogenics, Inc.	LYC	Class II	1997-03-11
K963894	Smartguide	Ferguson Medical	FCG	Class II	1997-03-11
K963787	Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm	Conmedcorp	DRX	Class II	1997-03-11
K963608	Quantitative Sentinel System	Quantitative Medicine, Inc.	HGM	Class II	1997-03-11
K963388	Vessel Dilator	Maxxim Medical	DRE	Class II	1997-03-11
K963273	Vcar Option to Vision Fx-80 Gamma Camera and Power Station	Smv America	KPS	Class II	1997-03-11
K963001	Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear	Permeable Technologies, Inc.	LPL	Class II	1997-03-11
K962605	Pro-Guard Double-Duty Sterilization Wrap (Single Use)	Surgicot, Inc.	FRG	Class II	1997-03-11
K961707	Trach-Eze Closed Ventilation Suction System	Sorenson Critical Care	BSY	Class I	1997-03-11
K955841	Sleep System for Clinics & Research	Compumedics Ptd, Ltd.	MNR	Class II	1997-03-11
K970666	Liquicheck Urine Toxicology Negative Control	Bio-Rad	DIF	Class I	1997-03-10
K970477	Hyragel ISO-Ldh Kit/hydragel 15 ISO-Ldh Kit	Sebia	CFE	Class II	1997-03-10
K970387	Human Chorionic Gonadotropin Method	Dade Chemistry Systems, Inc.	DHA	Class II	1997-03-10
K970385	Sparflozacin, 5 Mcg, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1997-03-10
K970360	Mitek Suture Retrograder	Mitek Products	HWQ	Class I	1997-03-10
K970357	Episcreen	Epitope, Inc.	PJD	Class II	1997-03-10
K970286	Presbyterian Linen Services Surgical Packs	MEDLINE INDUSTRIES, LP - Northfield	LRO	Class II	1997-03-10
K970100	Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control	Simplicity Diagnostics, Inc.	MJX	Class I	1997-03-10
K965240	Synchron Lx 20 Clinical Chemistry System, Synchron Lx Albumin Reagent, Synchron Lx Creatinine Picric Reagent, Synchron L	Beckman Instruments, Inc.	JJE	Class I	1997-03-10
K965146	Flat Closed Wound Drain with Trocar	Axiom Medical, Inc.	GBX	Class I	1997-03-10
K965115	Round Window Cath	Neuro-Biometrix, Inc.	ETD	Class II	1997-03-10
K965043	3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830Fs Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shie	Minnesota Mining and Mfg. Co.	FXX	Class II	1997-03-10
K965040	Introl Bladder Neck Support Prosthesis with Removal Tool	Johnson & Johnson MEDICAL GmbH	HHW	Class II	1997-03-10
K964973	Gish Cap Vrf45 Cardiotomy/venous Reservoir	Gish Biomedical, Inc.	DTN	Class II	1997-03-10
K964959	Vascutek Twillweave Vascular Graft	Vascutek, Ltd.	DSY	Class II	1997-03-10
K964910	Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders	Alpha Omega Services Inc	JAQ	Class II	1997-03-10
K964909	Esterm Malleus Total and Partial Middle Ear Prosthesis	Xomed, Inc.	ETB	Class II	1997-03-10
K964865	Pvk-720St Endocavitary Transducer	Toshiba America Medical Systems, In.C	ITX	Class II	1997-03-10
K964604	Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation	BIOTRONIK AG	DTB	Class III	1997-03-10
K964538	R-Port Standard Implantable Vascular Access System	Boston Scientific Corporation	LJT	Class II	1997-03-10
K964231	Nasp Hydrocolloid Dressing (Regular or Thin)	North American Sterilization & Packaging Co.	KMF	Class I	1997-03-10
K962323	Immulite Opiates Screen/control Module	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1997-03-10
K961269	Pulsemaster	American Dental Technologies, Inc.	GEX	Class II	1997-03-10