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 1935 of 3531

510(k) clearances, page 1935 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963699	Belray/model 096, Dental Intraoral X-Ray	Belmont Equipment Corp.	EHD	Class II	1996-12-23
K963111	Coatest Apc (Tm) Resistance V/coatest Apc (Tm) Resistance V S	Chromogenix AB	GGW	Class II	1996-12-23
K962976	Pharmacia Cap System Rast Feia	Pharmacia & Upjohn Company LLC	DHB	Class II	1996-12-23
K962840	Ecolotion Transmission and Massage Lotion	Eco-Med Pharmaceuticals, Inc.	ITX	Class II	1996-12-23
K962226	Protectiv 2000 i.v. Catheter Safety System	Johnson & Johnson MEDICAL GmbH	FOZ	Class II	1996-12-23
K962138	Flexart V3.1 Software	Toshiba America Mri, Inc.	LNH	Class II	1996-12-23
K962093	Ultramix	Sonotech, Inc.	ITX	Class II	1996-12-23
K961601	H.a.m. Applicator	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	1996-12-23
K960982	Monoject Blunt i.v. Access Cannula/monoject Hypodermic Syringe with Blunt i.v. Access Cannula	Sherwood Medical Co.	FMI	Class II	1996-12-23
K960948	Scatter Correction Volume Software Model Nssc-020A	Toshiba Medical Systems	KPS	Class II	1996-12-23
K960854	Siemens Servo Ultra Nebulizer 345	Pacesetter, Inc.	CAF	Class II	1996-12-23
K960492	Si Controller Model Si 500	I.C. Medical, Inc.	BTA	Class II	1996-12-23
K940242	Ventana Cea Primary Antibody	Ventana Medical Systems Inc	DFD	Class II	1996-12-23
K964838	Palladia 85 (Pm-13)	Gateway Alloys, Inc.	EJT	Class II	1996-12-20
K964837	Pacific 56 (Cb-40)	Gateway Alloys, Inc.	EJT	Class II	1996-12-20
K964792	La Plata 40	Gateway Alloys, Inc.	EJT	Class II	1996-12-20
K964789	La Plata 39	Gateway Alloys, Inc.	EJT	Class II	1996-12-20
K964788	El Dorado 55	Gateway Alloys, Inc.	EJT	Class II	1996-12-20
K964774	Punctum Plugs & Ready-Set Punctal Plugs	Fci Ophthalmics, Inc.	LZU	Unclassified	1996-12-20
K964621	A & E Medical Electrocautery Suction Tube with Finger Tip Activator Button	Alto Development Corp	GEI	Class II	1996-12-20
K964519	Curity Thoracentesis Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	GCX	Class II	1996-12-20
K964443	Surgiform Anatomical Malar	Surgical Technology Laboratories Inc.	LZK	Class II	1996-12-20
K964222	Acu-Clens Cleaning System for Contact Lens Cleaning	Paladin Medical, Inc.	LYL	Class II	1996-12-20
K964215	Acufex Mosaicplasty Comprehensive System	Smith & Nephew Endoscopy, Inc.	HRX	Class II	1996-12-20
K963960	Ksea Unimat Plus	Karl Storz Endoscopy-America, Inc.	HET	Class II	1996-12-20
K963837	Horizon/westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut from Lens Blan	Westcon Contact Lens Co., Inc.	LPL	Class II	1996-12-20
K963825	Auto Suture* Abbi* System	United States Surgical, A Division of Tyco Healthc	KNW	Class II	1996-12-20
K963417	Vitlite (Tr7700)	Escalon Trek Medical	MPA	Class II	1996-12-20
K962928	Combined Intracranial Pressure-Temperature Sensing System (Icp/)	Camino Neurocare, Inc.	GWM	Class II	1996-12-20
K962474	Olympus Fg Series of Rat Tooth Grasping Forceps (Urology)	OLYMPUS Corporation of the Americas	FBO	Class II	1996-12-20
K962424	Npb-4000	Analogic Corp.	MHX	Class II	1996-12-20
K962148	Verge Videometer	Verg, Inc.	FXN	Class I	1996-12-20
K961013	Disposable Needle Electrode	Medelec Intl. Corp.	IKT	Class II	1996-12-20
K955324	BIPAP S/t-D 30 System	Respironics, Inc.	MNT	Class II	1996-12-20
K955265	Cordis Sharp-Ended Stylet; Blunt-Ended Stylet; Cyst Puncture Catheter	Cordis US Corp.	JXG	Class II	1996-12-20
K953269	Safecircuit Manifold/pulmonary Unit	Advanced Warming Systems, Inc.	CBN	Class II	1996-12-20
K952721	Rubascan Card Test	BD Becton Dickinson Vacutainer Systems Preanalytic	LFX	Class II	1996-12-20
K964828	Virex II 128 Germicidal Cleaner and Deodorant	S.C. Johnson & Son, Inc.	LRJ	Class I	1996-12-19
K964059	Micadent	Hampton Research	KOJ	Class II	1996-12-19
K963959	Osteonics Modular Acetabular Cup (Ha-Coated Version)	Osteonics Corp.	MEH	Class II	1996-12-19
K963949	Ksea Unimat Plus	Karl Storz Endoscopy-America, Inc.	HET	Class II	1996-12-19
K963771	Chloroprene Exam Gloves	P.T. Irama Dinamika Latex	LZA	Class I	1996-12-19
K963465	Pelvic Holder	DeRoyal Industries, Inc.	FMQ	Class I	1996-12-19
K962518	Nitrile Copolymer Patient Examination Gloves	P.T. Irama Dinamika Latex	LZA	Class I	1996-12-19
K962139	Safeskin	Safeskin Corp.	LZA	Class I	1996-12-19
K945410	Irt Locking Syringe	Interventional Research Technologies	FMF	Class II	1996-12-19
K964721	Vitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators (Gem.c005)	Johnson & Johnson Clinical Diagnostics, Inc.	KLI	Class II	1996-12-18
K964459	Universal Reagent Factor X Deficient Plasma	Universal Reagents, Inc.	GGP	Class II	1996-12-18
K964442	Valproic Acid Assay for the Technicon Immuno 1 System	Bayer Corp.	LEG	Class II	1996-12-18
K964270	Universal Reagent Factor V Deficient Plasma	Universal Reagents, Inc.	GGP	Class II	1996-12-18