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 1376 of 3531

510(k) clearances, page 1376 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040542	Smith & Nephew Gts Sleeve and Gts Tapered Screw	Smith & Nephew, Inc.	HWC	Class II	2004-08-19
K040529	Cocoon Hygienist	Satelec	EIA	Class I	2004-08-19
K042140	Olympus Bf Type Uc160-Ol8	Olympus Corp.	ODG	Class II	2004-08-18
K041933	Microselectron Pdr	Nucletron BV	JAQ	Class II	2004-08-18
K041932	Oec Olympus Fluoroscopic Imaging System	GE Healthcare	OWB	Class II	2004-08-18
K041687	Abbott Immunoassay/clinical Chemistry Single Analyte Quality Control Materials (Assayed) and Abbott Estradiol Calibrator	Abbott Medical	JJX	Class I	2004-08-18
K041643	Synchron Systems Phosphorus (Phs) Reagent	Siemens Healthcare Diagnostics Inc.	CEO	Class I	2004-08-18
K040922	Venture Wire Control Catheter	Velocimed, Inc.	DQY	Class II	2004-08-18
K040799	Hommed Genesis Patient Monitor System with Options	Hommed, LLC	DXN	Class II	2004-08-18
K040490	Welch Allyn Spot Ultra Vital Signs Device	Welch Allyn Inc	DXN	Class II	2004-08-18
K041939	Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers	Blackstone Medical, Inc.	MQP	Class II	2004-08-17
K041666	Dc-Aceta/sal Controls	Sekisui Diagnostics P.E.I. Inc.	DIF	Class I	2004-08-17
K041393	Fassier-Duval Telscopic Im System	Orthopediatrics Canada ULC	HSB	Class II	2004-08-17
K041205	Expedium Anterior Spine System	DePuy Spine, Inc.	KWQ	Class II	2004-08-17
K040525	Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000	Sontra Medical, Inc.	NRJ	Class II	2004-08-17
K040108	Opue-E Disposable Powder Free Vinyl Synthetic Exam Gloves with Vitamin Complex, Nopal and Lanolin	Est International Corporation	LYZ	Class I	2004-08-17
K031152	Propper Vapor Line Pcd (Steam Sterilization Process Challenge Test)	Propper Mfg Co Inc	JOJ	Class II	2004-08-17
K042103	Nva-63-8-a and Nva-63-16-a Neurovascular Array Coil	Mri Devices Corp.	MOS	Class II	2004-08-16
K042055	Cypress Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-08-16
K041998	Phaco Chop Needles	Bausch & Lomb Incorporated	HQC	Class II	2004-08-16
K041993	2 Cm Peripheral Cutting Baloon	Boston Scientific Ivt	PNO	Class II	2004-08-16
K041973	Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	DQX	Class II	2004-08-16
K041947	I3 System-Abd Diagnostic Ultrasound	Innovative Imaging, Inc.	IYO	Class II	2004-08-16
K041946	Acon Spectrum Urine/serum Pregnancy Test Device	Acon Laboratories, Inc.	JHI	Class II	2004-08-16
K041935	Dr Systems Pacs, Release 6.1	Dr Systems, Inc.	LLZ	Class II	2004-08-16
K041898	Cliniqa Liquid Qc Tdm Controls Levels 1,2 & 3/Cliniqa Linical Tdm Calibration Verifiers Levels a-E for Olympus Au System	Cliniqa Corporation	JJX	Class I	2004-08-16
K041878	N Latex Cystatin	Siemens Healthcare Diagnostics Inc.	NDY	Class II	2004-08-16
K041871	Interlab Microcal Serum Controls	Trouble Shooter Consuling, Inc.	JJX	Class I	2004-08-16
K041782	Seemor 5.0 Image Display Program	Areeda Assoc., Ltd.	LLZ	Class II	2004-08-16
K041650	Micro Prime	Innovx Medical, Inc.	DWF	Class II	2004-08-16
K041635	G5 I Hba1c Test, G5 II Hba1c Test	Provalis Diagnostics, Ltd.	LCP	Class II	2004-08-16
K041604	Macro-Micro Depth Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	2004-08-16
K041461	Kmi Distal Volar Radius Plate System	Kinetikos Medical, Inc.	HRS	Class II	2004-08-16
K041447	Nuvasive Anterior Cervical Plate System	NuVasive Inc	KWQ	Class II	2004-08-16
K041194	Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H	Medical Analysis Systems, Inc.	JJX	Class I	2004-08-16
K040819	Transducer for Ultrasound Fetal Monitoring, Models Fm10833 and Fm10834	American I.V. Products, Inc.	HGM	Class II	2004-08-16
K033918	Ebi Lactosorb Graft Containment System	Ebi, LLC	HRS	Class II	2004-08-16
K033707	Polygraft Tcp Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-Xx, 600-025-Xx, 600-026-Xx, 600-022-Xx, 600-027-Xx	Osteobiologics, Inc.	MQV	Class II	2004-08-16
K032975	Jms Blood Tubing Sets	JMS North America Corp.	FJK	Class II	2004-08-16
K032742	Silver Foam Wound Dressing	Advanced Medical Solutions Limited	FRO	Unclassified	2004-08-16
K031714	Inion Trinion Biodegradable Meniscus Screw	Inion Oy	HWC	Class II	2004-08-16
K042124	Denfil	Vericom Co., Ltd.	EBF	Class II	2004-08-13
K042044	Acuson Cv70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-08-13
K041445	Immunocard Stat! Rsv Model #750630	Meridian Bioscience Inc	GQG	Class I	2004-08-13
K041262	Duralite-Gl	Laser Scientific	GEX	Class II	2004-08-13
K042022	E-Tac Ex-1000 Electrocardiographic Event Recorder	Datrix, Inc. dba of Jon Barron, Inc.	DXH	Class II	2004-08-12
K041985	Xps Curved Bur	Medtronic Xomed, Inc.	EQJ	Class I	2004-08-12
K041572	Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/ml	Becton Dickinson & Co	LON	Class II	2004-08-12
K041503	Hoverjack Air Patient Lift Device	D.T. Davis Enterprises Ltd.	FNG	Class II	2004-08-12
K041320	Modification to Nc-Stat	Neurometrix, Inc.	JXE	Class II	2004-08-12