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 1928 of 3531

510(k) clearances, page 1928 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962291	Siemens Sc9000/sc9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	DSI	Class II	1997-01-29
K961897	Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle	Wilson-Cook Medical Inc.	FCG	Class II	1997-01-29
K961346	Ph Analysis Module	Synectics-Dantec	FFT	Class I	1997-01-29
K955847	Gyro Tip Ep Catheter	Cardiac Assist Devices, Inc.	DRF	Class II	1997-01-29
K955802	Pathfinder	Cardima, Inc.	DRF	Class II	1997-01-29
K922668	Pilot Model 9200 Blood Pressure Measurement System	Colin Medical Instruments Corp.	MHX	Class II	1997-01-29
K970056	Solos, Cideo Camera Replacement Cable, 800/900 Series	Woodbine Optical Corp.	GCJ	Class II	1997-01-28
K965067	Dilation Catheter, Balloon	Boston Scientific Corporation	GBM	Class II	1997-01-28
K965061	Vidamed Modedl 7600 RF Generator	Vidamed, Inc.	GEI	Class II	1997-01-28
K964919	Emerald Medical, Inc. Nucleus Pulposis Evacuator System	Emerald Medical, Inc.	HRX	Class II	1997-01-28
K964611	Transend Guidewire	Boston Scientific Corporation	DQX	Class II	1997-01-28
K964399	Dale Endotracheal Tube Holder 270/280	Dale Medical Products, Inc.	CBH	Class I	1997-01-28
K964352	Torque Device	B.Braun Medical, Inc.	DQX	Class II	1997-01-28
K963067	Sof. Press Epc 51 System	Gaymar Industries, Inc.	JOW	Class II	1997-01-28
K962689	Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (Prp)	LivaNova USA, Inc.	CAC	Class II	1997-01-28
K970059	Kodak Miniloader(2000)	Eastman Kodak Company	IXW	Class II	1997-01-27
K965096	Fluoroview Series Fluoroscopic Tables	U.S. Imaging Tables, Inc.	IXR	Class II	1997-01-27
K965072	Panoura Ultra Pan and Panoura Ultra Pan/ceph Panoramic/cephalometric X-Ray Unit	Kaycor Intl., Ltd.	EHD	Class II	1997-01-27
K965063	Audiotone (a-552)	Miracle-Ear, Inc.	ESD	Class I	1997-01-27
K965057	Audiotone (A554h)	Miracle-Ear, Inc.	ESD	Class I	1997-01-27
K965049	Dahlberg (a-554)	Miracle-Ear, Inc.	ESD	Class I	1997-01-27
K965048	Vitros Immunoddiagnostics Products Re Controls (Gem.5015)	Johnson & Johnson Clinical Diagnostics, Inc.	JJY	Class I	1997-01-27
K964761	S.a.m. Facial Implant W/introducer	W. L. Gore & Associates, Inc.	FTL	Class II	1997-01-27
K964685	Dynamometer	John Chatillon & Sons, Inc.	LBB	Class II	1997-01-27
K964675	H.pylori Controls	Pyramid Biological Corp.	LYR	Class I	1997-01-27
K964433	Aquabond Electrode	Medibond, Ltd.	GXY	Class II	1997-01-27
K964414	Lr 5200 Laser Film Recorder	Bayer Corp., Agfa Div.	LMC	Class II	1997-01-27
K964395	Patient Specific Implant (Psi) Hip Femoral Component	Hayes Medical, Inc.	LZO	Class II	1997-01-27
K964384	Model D-290P Administration Set	Patient Solutions, Inc.	FPA	Class II	1997-01-27
K964357	Natural-Hip System Cocr Stem	Intermedics Orthopedics	LZO	Class II	1997-01-27
K964280	Dg Nervus	Medelec, Ltd.	GWQ	Class II	1997-01-27
K963998	Metal Backed Acetabular Component	Encore Orthopedics, Inc.	LPH	Class II	1997-01-27
K963946	Osteonics Modular Acetabular Cup (Microstructured Version)	Osteonics Corp.	LPH	Class II	1997-01-27
K963929	Jobst Athrombic Pump System 2100	Jobst A Beiersdorf Co.	JOW	Class II	1997-01-27
K963675	The Flat Panel Steirle Drape System(tm), Video Monitor Sterile Drape	Micro Medical Devices, Inc.	KKX	Class II	1997-01-27
K963509	Global Taper Tapered Hip System, Gt Spectron	Smith & Nephew Richards, Inc.	LPH	Class II	1997-01-27
K962854	Hardware:cardio Perfect Portable, Cardio Perfect Md and Software:cardio Perfect (V. 4.0 and Up for Dos), Cardio Perfect	Cardio Control BV	LOS		1997-01-27
K962655	Aneroid and Mercurial Sphygmomanometers	American Diagnostic Corp.	DXQ	Class II	1997-01-27
K962654	Compleat Surgical Mask	Carl Parker Associates, Inc.	FXX	Class II	1997-01-27
K961560	Eclipse 2000	Cardiogenes	GEX	Class II	1997-01-27
K970082	Abbott Advisor One-Step Pregnancy Test	Abbott Medical	LCX	Class II	1997-01-24
K965218	Senso Digital (C18)	Widex Hearing Aid Co., Inc.	ESD	Class I	1997-01-24
K965156	Ultima*unipolar Head and Adapter Sleeves	Johnson & Johnson Professionals, Inc.	KWL	Class II	1997-01-24
K965088	M11 Series: M11, M11m	Philips Hearing Instruments Co.	ESD	Class I	1997-01-24
K965054	Pencil	Megadyne Medical Products, Inc	GEI	Class II	1997-01-24
K964937	A Lithotripter-Compatible Basket	Boston Scientific Corporation	LQC	Class II	1997-01-24
K964817	Derlin	Derlin Company, Ltd.	LYY	Class I	1997-01-24
K964764	Opus Bone Alp	Behring Diagnostics, Inc.	CIN	Class II	1997-01-24
K964746	Hispeed Ct/i with Performix Tube and Warp Scan Option	GE Healthcare	JAK	Class II	1997-01-24
K964704	Depuy/ace Modified Medical Aspect (Mma) Fracture Stem	Depuy, Inc.	LZO	Class II	1997-01-24