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 2026-11-02, 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 2419 of 3531

510(k) clearances, page 2419 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913332	Ciba Corning Model 270 Co-Oximeter	Ciba Corning Diagnostics Corp.	DQA	Class II	1991-10-23
K913328	.010 Hi-Torque Plus(tm) Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1991-10-23
K913143	Ochsner Ulp Bifurcation Vascular Prothesis	Intervascular, Inc.	DSY	Class II	1991-10-23
K913081	Multi-View Bifocals	Camp Contact Lenses	HPX	Unclassified	1991-10-23
K913014	Ems Percussor	Engineered Medical Systems, LLC	BYI	Class II	1991-10-23
K912773	Unipolar Upsizing Adaptor	Telectronics Pacing Systems, Inc.	DTD	Class II	1991-10-23
K912504	Disposable Anesthesia Breathing Circuits, Modified	Intertech Resources, Inc.	CAI	Class I	1991-10-23
K912397	Professional Indirect Ophthalmoscope	Clement Clarke, Inc.	HLI	Class II	1991-10-23
K912158	Central Venous Catheter Dressing Change Tray	Medical Device Inspection Company	FOZ	Class II	1991-10-23
K912079	Sarns Smoc Membrane Oxy W/integrat Card Res,modify	3M Health Care, Sarns	DTZ	Class II	1991-10-23
K912065	Disposable Anesthesia Breathing Circuits, Modified	Intertech Resources, Inc.	CAI	Class I	1991-10-23
K911807	Metered Dose Inhaler (Mdi) Spacer	Health Products, Inc.	CAF	Class II	1991-10-23
K911739	Swemac Reison Biplanar 300	Seemac Reison AB Co.	OXO	Class II	1991-10-23
K911726	Programmable Auditory Comparator, Modification	Bausch & Lomb Incorporated	KHL	Class II	1991-10-23
K911710	Heparin Coated Thermodilution Cath & Accessories	Sunscope Intl., Inc.	DQO	Class II	1991-10-23
K911563	Inventor Rt/explorer Trauma Unit	Continental X-Ray Corp.	IYB	Class I	1991-10-23
K911422	Drug Nebulizers	Intersurgical Ltd.	CAF	Class II	1991-10-23
K911364	Spoon Forceps, 11Mm	Northgate Technologies Inc.	LQC	Class II	1991-10-23
K914477	Audiotone Model a-95 Behind-the-Ear Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-10-21
K914418	Act-II Behind the Ear Hearing Aid	Telex Communications, Inc.	ESD	Class I	1991-10-21
K914261	Abbott Quickstart Ld-1,#5A30	Em Diagnostic Systems, Inc.	JGF	Class II	1991-10-21
K914074	8000 Series Volumetric Pump Solution Set	Baxter Healthcare Corporation	FPA	Class II	1991-10-21
K914073	F21(r) Dental Cement	Voco GmbH	EMA	Class II	1991-10-21
K913895	Flo-Gard(r) 6200, 6300 & 8000	Baxter Healthcare Corporation	FRN	Class II	1991-10-21
K913754	Cardio 500	Kontron Elektronik GmbH	LLZ	Class II	1991-10-21
K913741	Il Test(tm) Dat Cal/control Set C	Instrumentation Laboratory Co.	DKB	Class II	1991-10-21
K913740	Il Test(tm) Dat Cal/control Set B	Instrumentation Laboratory Co.	DKB	Class II	1991-10-21
K913640	Dr. Dean Edell Solarbloc Sunglasses	Cable Car Sunglasses	HQY	Class I	1991-10-21
K913585	Lipase Linearity Control	Creative Laboratory Products, Inc.	JJX	Class I	1991-10-21
K913530	Look Viscodissector	Look, Inc.	HQC	Class II	1991-10-21
K913465	Nidek Models Ac-2100 & 2200	Nidek, Inc.	GEX	Class II	1991-10-21
K913444	Globalcare Ems	Globalcare Intl., Inc.	IPF	Class II	1991-10-21
K913441	Model #Sct-32 Auto Quadrature Spine Coil Transport	Mri Devices Corp.	LNH	Class II	1991-10-21
K913282	Lima Rps Shoulder	Turnkey Intergration USA, Inc.	HSD	Class II	1991-10-21
K913276	Microtek Medical's Sound Stiks	Microbio-Medics, Inc.	EWO	Class II	1991-10-21
K913266	Micro-Aire Model 2050E/elec Handpiece/trottleless	Micro Surgical Instruments Corp.	GEY	Class I	1991-10-21
K913161	Merit Manifold	Merit Medical Systems, Inc.	DTL	Class II	1991-10-21
K912492	Evacuation/irrigation/elecrosurgical Device	Ethicon, Inc	GCJ	Class II	1991-10-21
K912180	Model Mgb-301 Diaphragm Film 24 X 30 Cm	Instrumentarium Imaging, Inc.	IZX	Class II	1991-10-21
K911689	Model 330 Screening Audiometer	Virtual Corp.	EWO	Class II	1991-10-21
K911655	Implarette	Implant Innovations International, Inc.	EKJ	Class I	1991-10-21
K911260	Atraumatic Standard Sprotte Needle	Pajunk GmbH Medizintechnologie	BSP	Class II	1991-10-21
K904655	Pyloriset	Orion Diagnostica, Inc.	LYR	Class I	1991-10-21
K904652	Lyme Stat M Test Kit	Whittaker Bioproducts, Inc.	LSR	Class II	1991-10-21
K914182	Golden Thermal(r)	Seabrook Medical Systems, Inc.	ILO	Class II	1991-10-18
K914007	Cordis 5.2 French Super Torque Plus Cardio Cath	Cordis US Corp.	DQO	Class II	1991-10-18
K913967	Dox Tamperproof Specimen Container System	Doxtech, Inc.	KDW	Class I	1991-10-18
K913861	Hemochron(r) Kact	Accriva Diagnostics, Inc.	JBP	Class II	1991-10-18
K913783	Cordis Ptca Guiding Catheter, Modification	Dow Corning Wright	DQY	Class II	1991-10-18
K913729	Polar Pump, Model 500	Breg, Inc.	ILO	Class II	1991-10-18