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 1475 of 3531

510(k) clearances, page 1475 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023111	Gyrus Plasma Skin Resurfacing System	Gyrus ACMI, Inc.	GEI	Class II	2003-03-13
K023105	Atac Calcium Reagent and Atac Calibrator	Elan Diagnostics	CIC	Class II	2003-03-13
K022923	Candela Gentle Yag Laser System	Candela Corporation	GEX	Class II	2003-03-13
K030745	Gammamed 212 and 232 Source Assembly	Varian Medical Systems, Inc.	KXK	Class II	2003-03-12
K030038	Philips Mp60, Mp70 and Mp90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr	Philips North America LLC	MHX	Class II	2003-03-12
K030036	Triple-Cure Paste/paste Resin-Reinforced Glass Ionomer Cement	Pulpdent Corporation	DYH	Class II	2003-03-12
K024335	Candela Gentlelase Family of Laser Systems	Candela Corporation	GEX	Class II	2003-03-12
K024266	Msi Ta Electrodes	Medsphere International, Inc.	GEI	Class II	2003-03-12
K024214	Kavo Everest Titanblank	Kavo America	EJH	Class II	2003-03-12
K024201	Navigus Fiducial Marker System, Models Fm-1000, Fm-2000	Image-Guided Neurologics, Inc.	HAW	Class II	2003-03-12
K024138	Heat Scissors Generator Set and Heat Scissors Handpiece	Olympus Optical Co., Ltd.	GEI	Class II	2003-03-12
K024096	Optima, Spinal System	U&I Corp., America	MNI	Class II	2003-03-12
K023693	Mobile Particulate Contamination Control System, Model M-100	Airex, Inc.	FRF	Class II	2003-03-12
K022004	Cardiac Output Kit, Model Co-1 & Inline Sensor Cable, Model Ils-1	Biosensors International-USA	DQO	Class II	2003-03-12
K030557	Modification to Vnus Closure System	Vnus Medical Technologies, Inc.	GEI	Class II	2003-03-11
K030476	Modified Concentric Retriever, Model 90037	Concentric Medical, Inc.	DQY	Class II	2003-03-11
K030387	C.t.m. Mobility Scooter, Model Hs-890	C.T.M. Homecare Product, Inc.	INI	Class II	2003-03-11
K030185	Endos Ac/acp	Villa Sistemi Medicali S.p.A.	EHD	Class II	2003-03-11
K030118	Rapid Programmar	Abbott Medical	GZB	Class II	2003-03-11
K024284	Victoreen Thebes II, Model 7020	Syncor Radiation Management	IYE	Class II	2003-03-11
K024089	Vacuflash Biopsy System	Bip USA, Inc.	KNW	Class II	2003-03-11
K024087	Reprocessed Compression Sleeves	Alliance Medical Corp.	JOW	Class II	2003-03-11
K024085	Ccd Camera, Model Pkp-06000-000	Perkins Electronics Co.	IZJ	Class II	2003-03-11
K023564	Osse-Lign	Osseus, LLC	JDQ	Class II	2003-03-11
K023445	Tracers Bone Cement Opacifier	Parallax Medical, Inc.	MYU	Class II	2003-03-11
K023074	Imbibe Bone Marrow Aspiration Syringe	DSM Biomedical, Inc.	FMF	Class II	2003-03-11
K010705	Optidos	Ptw-New York Corp.	KXK	Class II	2003-03-11
K030538	American Catheter, Model W3	Catheter, LLC	EZD	Class II	2003-03-10
K030420	Lightspeed 5.0 Computed Tomography System	GE Healthcare	JAK	Class II	2003-03-10
K030409	Smart Nitinol Stent Endoscopic Biliary System	Cordis US Corp.	FGE	Class II	2003-03-10
K030242	Fyrelink	Mpacs, LLC	LLZ	Class II	2003-03-10
K030010	Atac Pak Magnesium Reagent	Elan Diagnostics	JGJ	Class I	2003-03-10
K024374	Rmo Plasma Curing Light	Lokki Lasers Medicaux	EBZ	Class II	2003-03-10
K024159	Strykerware System	Stryker Corp.	LLZ	Class II	2003-03-10
K024143	Aigis-Fine	Sb Lucius, Inc.	EJT	Class II	2003-03-10
K024142	Aigis-Super	Sb Lucius, Inc.	EJT	Class II	2003-03-10
K024136	Aigis-Soft	Sb Lucius, Inc.	EJT	Class II	2003-03-10
K024135	Aigis-Plus	Sb Lucius, Inc.	EJT	Class II	2003-03-10
K024077	Delwa-Star Ws-Fm Blood Pressure and Body Fat Monitor	Zewa, Inc.	DXN	Class II	2003-03-10
K023808	Irrigation Sets	Intl. Medsurg Connection, Inc.	LJH	Class II	2003-03-10
K023465	Kendro Heracell 240 Incubator	Kendro Laboratory Products, L.P.	MQG	Class II	2003-03-10
K023121	Lifestent Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2003-03-10
K030551	Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands	ArthroCare Corporation	GEI	Class II	2003-03-07
K030460	Modification to Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	PAG	Class II	2003-03-07
K030339	Cautery Tip Cleaner, Model-Tc-100	Aspen Surgical Products, Inc.	GEI	Class II	2003-03-07
K030164	Non-Sterile, Powder-Free, Polymer Coated, Natural And/or Violet and Black Color, Latex Examination Gloves with Protein	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	2003-03-07
K030015	Atac Pak Phosphorus Reagent	Elan Diagnostics	CEO	Class I	2003-03-07
K030006	Atac Pak Albumin Reagent	Elan Diagnostics	CIX	Class II	2003-03-07
K024205	Audioscreener Oae+abr	Everest Biomedical Instruments Co.	EWO	Class II	2003-03-07
K024178	Viatorr Endoprosthesis	W. L. Gore & Associates, Inc.	JCT	Class II	2003-03-07