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 1273 of 3531

510(k) clearances, page 1273 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060737	Sinmed Positioning Devices	Sinmed BV	IYE	Class II	2006-03-31
K060689	1.5T Pediatric Head and Spine Array Model	Resonance Innovations, LLC	MOS	Class II	2006-03-31
K060672	One Stick Y Extension Set and Volumeter	One Stick, LLC	FPA	Class II	2006-03-31
K060634	Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series	Spinal Concepts, Inc.	MNI	Class II	2006-03-31
K060550	Kodak Directview Dr 3000 System 64Kw/80kw Generators, Models 6551345, 6551386	Eastman Kodak Company	KPR	Class II	2006-03-31
K060542	Ge Vivid 7 Model Fc008xx, Ge Vivid 7 Model Fc009xx	General Electric Co.	IYN	Class II	2006-03-31
K060296	Nxstage Dialysate Preparation Module	NxStage Medical Inc	FKR	Class II	2006-03-31
K060269	Acmi Dur-Digital Ureteroscope and Choledochoscope System	Acmi Corporation	FBN	Class II	2006-03-31
K060255	E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return Electrode	E Surgical, LLC	GEI	Class II	2006-03-31
K060236	Mw-1000 Iontophoretic Drug Delivery Electrode	Iomed, Inc.	EGJ	Class II	2006-03-31
K060082	Tianjin Medis Disposable Infusion Set	Tianjin Medis International Trade Co., Ltd.	FPA	Class II	2006-03-31
K053583	Optivia Hysteroscopic Introducer, Optivia Steerable Working Channel	Optivia Medical, LLC	HIH	Class II	2006-03-31
K053569	Agility Lp Total Ankle Prosthesis	Depuy Orthopaedics Inc.	HSN	Class II	2006-03-31
K052914	Rx Imola	Randox Laboratories, Limited	CEM	Class II	2006-03-31
K052794	Eti-Max 3000	Diasorin Inc.	JJF	Class I	2006-03-31
K052515	Siroendo	Sirona Dental Systems GmbH	EKX	Class I	2006-03-31
K052424	Maxilim	Medicim NV	LLZ	Class II	2006-03-31
K050311	Atrium Medical Corporation C-Qur Mesh	Atrium Medical Corporation	FTL	Class II	2006-03-31
K060303	Vanguard Ps Open Box Porous Femoral Components	Biomet Manufacturing Corp	MBH	Class II	2006-03-30
K060124	Atrium Flixene Graft	Atrium Medical Corporation	DSY	Class II	2006-03-30
K060075	Fiber-Metal Post	Foremost Dental, LLC	ELR	Class I	2006-03-30
K060038	Sbi Radio-Capitellar Implant	Small Bone Innovations, Inc.	JDB	Class II	2006-03-30
K053366	Nitrile Examination Gloves, Powdered, Non Sterile	Pt Mahakarya Inti Buana	LZA	Class I	2006-03-30
K052693	Pm-50 Pulse Oximeter	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	DQA	Class II	2006-03-30
K051670	RF Tunneler Wire	Baylis Medical Co., Inc.	PDU	Class II	2006-03-30
K050123	P-Stim System	Neuroscience Therapy Corp.	BWK	Unclassified	2006-03-30
K060673	Pediatric Ureteral Stent	Applied Medical Resources Corp	FAD	Class II	2006-03-29
K060547	Access Breast Coil 4/Sms	Confirma, Inc.	MOS	Class II	2006-03-29
K060505	Voxar 3D Enterprise, Model 6.1	Barcoview Mis Edinburgh	LLZ	Class II	2006-03-29
K060493	Bd Phoenix Automated Microbiology System - Vancomycin-Gp Detection of Vrsa.	Becton Dickinson & Co	LON	Class II	2006-03-29
K060344	O-Arm Imaging System	Breakaway Imaging, LLC	OXO	Class II	2006-03-29
K060332	Orthoblast II Dbm Demineralized Bone Matrix Paste and Putty	Isotis NV	NUN	Class II	2006-03-29
K060310	Fraxel II Sr Laser System and Accessories	Reliant Technologies, Inc.	GEX	Class II	2006-03-29
K060298	Pill Phone	Vocel	NXQ	Class I	2006-03-29
K060197	Zargis Acoustic Cardioscan (Zac), Model Zac 6.28	Zargis Medical Corp.	DQD	Class II	2006-03-29
K060171	Cleanse S+ Ultrasonic Scaler	Dmetec.Co., Ltd.	ELC	Class II	2006-03-29
K060074	Interlink System-T-Connector Extension Set, Model 2N3326	Baxter Healthcare Corporation	FPA	Class II	2006-03-29
K053626	Interx500 Flexible Array Electrode	InterX Technologies	GXY	Class II	2006-03-29
K053521	Pre-Powdered Sterile Vinyl Glove, Clear	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	LYZ	Class I	2006-03-29
K053383	Fidis Celiac	Biomedical Diagnostics (Bmd) SA	MST	Class II	2006-03-29
K053368	Interproximal Reduction System	Dentsply International, Inc.	EFB	Class I	2006-03-29
K053123	Pd Cath	Med-Conduit, Inc.	FJS	Class II	2006-03-29
K052788	N Latex Hcy, N Protein Standard Sl, N/t Protein Control L/m/h	Siemens Healthcare Diagnostics Inc.	LPS	Class II	2006-03-29
K052525	Cybow 11 Series Reagent Strips for Urinalysis	DFI Co., Ltd.	JIL	Class II	2006-03-29
K052383	Innocure Imrt Filter (Compensators)	Innocure, LLC	IXI	Class II	2006-03-29
K052122	Bisco LED	Bisco Inc	EBZ	Class II	2006-03-29
K051753	Accu-Source	Oncology Systems, Inc.	JAQ	Class II	2006-03-29
K051058	Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls	Lin-Zhi International Inc	DJR	Class II	2006-03-29
K050945	Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls	Lin-Zhi International Inc	DIO	Class II	2006-03-29
K060543	Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800	Clinical Micro Sensors, Inc.	NUA	Class II	2006-03-28