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 2137 of 3531

510(k) clearances, page 2137 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940198	L-Cath Connector Assembly	Luther Medical Products, Inc.	GCD	Class I	1994-12-15
K935913	Howmedica Sentry S Total Hip System	Howmedica Corp.	LZO	Class II	1994-12-15
K934572	Unitone	Scitex Corporation, Ltd.	LLZ	Class II	1994-12-15
K933391	Atrium's Hybrid PTFE	Atrium Medical Corporation	DYF	Class II	1994-12-15
K930536	Neuromed Octrode Model Mnr-88A-B-C Neurostim Rec	Neuromed, Inc.	GZB	Class II	1994-12-15
K926312	Infrared Eye Movement Monitor	Microguide, Inc.	GWN	Class II	1994-12-15
K925678	Athena High Speed Handpiece	Athena Technology, Inc.	EFB	Class I	1994-12-15
K921871	Hysteromat(tm) 3700	F.M. Wiest USA, Inc.	HIG	Class II	1994-12-15
K945709	Sii 525 Ms	Scott Imaging Intl., Inc.	KPR	Class II	1994-12-14
K945708	Sii 360 Ms	Scott Imaging Intl., Inc.	KPR	Class II	1994-12-14
K945278	Philips Bucky Diagnost Family	Philips North America LLC	KPR	Class II	1994-12-14
K945276	Pro-Tec Disposable Sharps Containers 5G	Pro-Tec Containers, Inc.	FMI	Class II	1994-12-14
K945275	Pro-Tec Disposble Sharps Containers Q1	Pro-Tec Containers, Inc.	FMI	Class II	1994-12-14
K945274	Pro-Tec Disposable Sharps Containers Ir180 & Ir80	Pro-Tec Containers, Inc.	FMI	Class II	1994-12-14
K945273	Pro-Tech Disposable Sharps Containers Vnc2	Pro-Tec Containers, Inc.	FMI	Class II	1994-12-14
K945272	Rhodium Filter	Lorad Corp.	IZH	Class II	1994-12-14
K945113	Pulpdent Cervical Restorative	Pulpdent Corporation	EBF	Class II	1994-12-14
K945112	Pulpdent Dual Cure Unfilled Bonding Resin	Pulpdent Corporation	KLE	Class II	1994-12-14
K945058	Pulpdent Microfilled Anterior Composite	Pulpdent Corporation	EBF	Class II	1994-12-14
K945057	Pulpdent Hybrid Anterior Composite	Pulpdent Corporation	EBF	Class II	1994-12-14
K945056	Pulpdent Resin Cement	Pulpdent Corporation	EBF	Class II	1994-12-14
K945055	Harken Assure Self-Seal Sterilization Pouch	Harken Products, Inc.	KCT	Class II	1994-12-14
K945018	Pulpdent Hard Dental Posterior Filling Material	Pulpdent Corporation	EBF	Class II	1994-12-14
K944973	Nrf System	Philips North America LLC	JAA	Class II	1994-12-14
K944848	The Vivacare T.p.s. Probe	Rms Div.	EIX	Class I	1994-12-14
K943794	Mx4000	Bfi- Medical Waste Systems	FMI	Class II	1994-12-14
K943740	Roll-a-Way Sharps Disposal System (Red and Ivory)	Premium Plastics, Inc.	FMI	Class II	1994-12-14
K943016	Adobe C.i.c	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-12-14
K942911	Glycar Tissue Repair Patch	Glycar SA Pty., Ltd.	FTL	Class II	1994-12-14
K942826	Orthodonitc Metal Reinforced Plastic Bracket	Gac Intl., Inc.	DYW	Class II	1994-12-14
K942434	Bionaire Clear Air Air Purifier & Ionizer	Bionaire Corp.	FRF	Class II	1994-12-14
K942286	Diarlex Rota-Adeno	Orion Diagnostica, Inc.	LIQ	Class I	1994-12-14
K941171	Technicon H* 3 Rtc System (in-Vitro Diagnostic System)	Miles, Inc.	GKZ	Class II	1994-12-14
K935587	Multilink Shoulder Cpm Unit	Toronto Medical Corp.	BXB	Class I	1994-12-14
K945898	Electrosurgical Device, Cutting and Coagulation and Accessories	Megadyne Medical Products, Inc	GEI	Class II	1994-12-13
K945893	Disposable & Reusable Monopolar Electrosurigical Electrode	Boston Surgical Products, Inc.	GEI	Class II	1994-12-13
K945805	Wells Johnson Weco Monopolar/frazier Suction Probe	Wells Johnson Co.	GEI	Class II	1994-12-13
K945351	Shield, Eye, Ophthalmic	Taiwan Eva Industrial Co., Inc.	HOY	Class I	1994-12-13
K945350	Frame, Spectacles	Taiwan Eva Industrial Co., Inc.	HQZ	Class I	1994-12-13
K945289	Doa - Immunoassay Cut-Off Calibrator	Medi-Tech, Inc.	DKB	Class II	1994-12-13
K945263	Optus Thoracoscopes	Optus, Inc.	GCJ	Class II	1994-12-13
K944970	Solution	Freedom Designs Inc	IOR	Class I	1994-12-13
K944762	Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance Db Data Managementsoftware	Medtronic, Inc.	BZG	Class II	1994-12-13
K944637	Family Fitness Shiatsu Massager	Conair LLC.	ISA	Class I	1994-12-13
K944607	Model 5135 Auto Lp/flash	Richard Wolf Medical Instruments Corp.	GCT	Class II	1994-12-13
K944354	Contour Emboli	Interventional Therapeutics Corp.	HCG	Class II	1994-12-13
K944208	IV Administration Set Fpa	Medex, Inc.	FPA	Class II	1994-12-13
K944102	Ast Qvet	Prisma Systems	CIT	Class II	1994-12-13
K943045	Unimax Model 2500 Multiwavelength Color Corrected	Reliant Technologies, Inc.	GEX	Class II	1994-12-13
K943000	Albumin Qvet	Prisma Systems	CIX	Class II	1994-12-13