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 2370 of 3531

510(k) clearances, page 2370 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921474	Vita Omega Porcelain	Vident	EIH	Class II	1992-06-18
K920432	Bair Hugger Cub Blanket- Short Model 536	Augustine Medical, Inc.	DWJ	Class II	1992-06-18
K915694	Meditron Electronic Laparoscopic Insufflator	Medical Devices Inc.	HIF	Class II	1992-06-18
K912925	Ultra Pvd	Advanced Medical Products, Inc.	JAF	Class II	1992-06-18
K911916	Acuson C366 Transducer	Acuson Corp.	ITX	Class II	1992-06-18
K911065	Arrow Quadpolar Mapping/pacing Catheter	Arrow Intl., Inc.	DRF	Class II	1992-06-18
K921943	Schneider Monorail 421 Percu Trans Angio (Pta) Bal	Schneider Intl., Ltd.	LIT	Class II	1992-06-17
K921512	Entended Line Accessories & Connectors	Intersurgical Ltd.	BZA	Class I	1992-06-17
K921511	Catheter Mounts -- Modification	Intersurgical Ltd.	BZA	Class I	1992-06-17
K920938	Vjw2919 Pneumatic Compression Upgrade	Varian Canada, Inc.	IZH	Class II	1992-06-17
K915086	Hpi Brown Nitrile Sensi-Grip Surgical Gloves	Hpi, Inc.	KGO	Class I	1992-06-17
K914746	Dermagran Wet Dressing	Derma Sciences, Inc.	MGQ	Unclassified	1992-06-17
K922380	Bite Rim Wax	Dentsply Intl.	EGD	Class I	1992-06-16
K922307	Showerfloss Oral Irrigation Unit	Showerfloss, Inc.	EFS	Class I	1992-06-16
K922079	Rotolux, Selectolux, Shuttervue	American Medical Sales, Inc.	IXC	Class I	1992-06-16
K922043	Roche Calibrator Serum	Roche Diagnostic Systems, Inc.	JIX	Class II	1992-06-16
K922012	Shimadzu Image Amplifier Ia-12Vsa Series	Shimadzu Medical Systems	JAA	Class II	1992-06-16
K921820	Renamel Esthetic Restorative System, Modification	Cosmedent, Inc.	EBF	Class II	1992-06-16
K921746	Vitek Immunodiagnostic Assay System	Biomerieux Vitek, Inc.	CGJ	Class I	1992-06-16
K921689	Cedia Red Blood Cell Folate Reagent Pack	Microgenics Corporation	CGN	Class II	1992-06-16
K921601	Ultradent Prod Retract Cord/accessory Product Line	Ultradent Products Inc.	JES	Class I	1992-06-16
K921148	Cvis Insight Catheters for Intracardiac Use	Cardiovascular Imaging Systems, Inc.	ITX	Class II	1992-06-16
K921147	Cvis Insight Imaging Catheter for Intraluminal Use	Cardiovascular Imaging Systems, Inc.	ITX	Class II	1992-06-16
K920875	Prolonged Occlusion Dressing I	Ferndal Laboratories	FRO	Unclassified	1992-06-16
K920874	Prolonged Occlusion Dressing II	Ferndal Laboratories	FRO	Unclassified	1992-06-16
K920014	Il Test Immunoglobulin a	Instrumentation Laboratory Co.	CZP	Class II	1992-06-16
K920007	Il Test Complement 3	Instrumentation Laboratory Co.	CZW	Class II	1992-06-16
K913912	Verimed Perineometer	Verimed Holdings, Inc.	HIR	Class II	1992-06-16
K913320	Mil Cm-II Coagulation Machine	Medical Innovations, Inc.	GKN	Class II	1992-06-16
K912067	Polaris, Gynecology Indications	Pfizer Laser Systems	GEX	Class II	1992-06-16
K921834	Automates Coma Cocaine Metabolite Assay	Serex, Inc.	DIO	Class II	1992-06-15
K921609	Vista Hp/hpq System	Philips North America LLC	LNH	Class II	1992-06-15
K921376	Patient Examination Gloves	Seal Polymer Industries Bhd.	LYY	Class I	1992-06-15
K920183	Tech Dyne - Hp-2000, Skreen Test, Rms-200	Tech Dyne Group	LBB	Class II	1992-06-15
K915651	Omnimed Holmium Laser and Delivery System	Summit Technology, Inc.	GEX	Class II	1992-06-15
K915646	Vivus 50 and Vivus 100 Personal Infuser	Halyard Health	FRN	Class II	1992-06-15
K915631	Lpi Ml 100/532 and Ml 532 Surgical Laser	Laser Photonics, Inc.	GEX	Class II	1992-06-15
K915578	Nd;yag Surgical Laser Systems	Heraeus Lasersonics, Inc.	GEX	Class II	1992-06-15
K921251	Cusa System 200C and 200T Ultrasonic Aspirator	Medtronic, Inc.	LFL	Unclassified	1992-06-12
K915116	Trocar Sheath Anchor	Origin Medsystems, Inc.	HET	Class II	1992-06-12
K922338	X-330/Spirit Motorized Three-Wheeled Scooter	Am Scooters	INI	Class II	1992-06-11
K922227	Model #225-St Shock-Trode Adult Defib Pads Sterile	Cardiotronics, Inc.	LDD	Class II	1992-06-11
K922185	Jace Knee Extension System -- Modification	Jace Systems, Inc.	BXB	Class I	1992-06-11
K922173	Model # 830 St Adult Stimulation Pads (Sterile)	Cardiotronics, Inc.	LDD	Class II	1992-06-11
K922172	Model # 230 St Stealth-Trode Defib Pads (Sterile)	Cardiotronics, Inc.	LDD	Class II	1992-06-11
K921510	Gas Sampling Kit Modification	Respiratory Support Products, Inc.	BZO	Class I	1992-06-11
K921353	Nasopharyngeal Airway	Coast Medical Corp.	BTQ	Class I	1992-06-11
K921214	Ophthalmic Projector	Luneau Ophtalmologie SA	HOS	Class I	1992-06-11
K920686	Ortho-Plex-Rehabilitation System	Plexus Intl., Inc.	BXB	Class I	1992-06-11
K920423	Olympic Smart Scale Care Center	Olympic Medical Corp.	FEW	Class II	1992-06-11