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 1557 of 3531

510(k) clearances, page 1557 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013922	Coronis 3Mp Medicl Flat Panel Display System	Barco N.V.	LLZ	Class II	2002-01-28
K013852	Jobst Ready-to-Wear Gauntlet	BSN-Jobst GmbH	DWL	Class II	2002-01-28
K013673	Hi-Art System	Tomo Therapy, Inc.	MUJ	Class II	2002-01-28
K013667	Bcc Gamma Camera	Is2 Research, Inc.	KPS	Class II	2002-01-28
K013585	Mediport 2000 Mobile	Servox Medizintechnik GmbH	BTA	Class II	2002-01-28
K013584	Excite Self Etch	Ivoclar Vivadent, Inc.	KLE	Class II	2002-01-28
K012089	Catheffects' Desai Vectorcath Mapping System	Catheffects, LLC	DQK	Class II	2002-01-28
K011533	Depuy Femoral Heads	Depuy Orthopaedics Inc.	LZO	Class II	2002-01-28
K010378	Hedrocel Vertebral Body Replacement, Model Xx-Yyy-Zzzz	Implex Corp.	MQP	Class II	2002-01-28
K002142	Saline IV Flush Syringe	Emt-Rx	FOZ	Class II	2002-01-28
K020133	Modification to the Maestro System	BioHorizons Implant Systems Inc	DZE	Class II	2002-01-25
K014294	Modification to Escort II+ 400 Series 9Escort Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412, 20413, 20414	Medical Data Electronics	DQA	Class II	2002-01-25
K014267	Butterfly Plate Fixation System	Medtronic Sofamor Danek	KWP	Class II	2002-01-25
K014229	Modification to Opus Spinal System	Howmedica Osteonics Corp	MNH	Class II	2002-01-25
K014226	Unitrax Modular Unipolar System	Howmedica Osteonics Corp	KWL	Class II	2002-01-25
K014223	Modification to Guardwire Plus Temporary Occlusion & Aspiration System	Medtronic Percusurge, Inc.	NFA	Class II	2002-01-25
K014220	T2 Femoral Nail System	Howmedica Osteonics Corp	HSB	Class II	2002-01-25
K013881	Ribbond - Triaxial	Ribbond, Inc.	EBI	Class II	2002-01-25
K013629	Finger Joint Prosthesis	Avanta Orthopaedics, Inc.	KYJ	Class II	2002-01-25
K013610	Perifix Safety Epidural Needles	B.Braun Medical, Inc.	BSP	Class II	2002-01-25
K013577	Ultramax Woven Velour Vascular Graft	Atrium Medical Corporation	DSY	Class II	2002-01-25
K013576	Pericscope, Model # Perisc1	Ethicon Endo-Surgery Inc	GCJ	Class II	2002-01-25
K013575	Kps-I, the Kidney Perfusion Solution	Organ Recovery Systems, Inc.	KDN	Class II	2002-01-25
K013507	Cosmo TENS Pf-990 Mini Digital Wireless Patch	Cosmo Health, Inc.	GZJ	Class II	2002-01-25
K013392	Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880	Medtronic, Inc.	OCL	Class II	2002-01-25
K013091	Zmm 2000 Zeppelin Millennium Motordrill System	Von Zeppelin GmbH	HBB	Class II	2002-01-25
K012937	Knee Module for the Stealthstation System	Medtronic Navigation, Inc	HAW	Class II	2002-01-25
K011074	Cryocare Surgical System	Varian Medical Systems, Inc.	GEH	Class II	2002-01-25
K014238	Delsonic 2000	Deldent, Ltd.	ELC	Class II	2002-01-24
K014233	Captiam Syphilis-G Assay	Trinity Biotech, PLC	LIP	Class II	2002-01-24
K014008	Hemochron Jr. Citrate Aptt Cuvette	Itc, Inc.	GFO	Class II	2002-01-24
K013964	Modification to Accu-Space Plain Gut Absorbable Seeding Spacers	Cp Medical	KXK	Class II	2002-01-24
K013899	Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Calibrators	Ortho-Clinical Diagnostics, Inc.	CDD	Class II	2002-01-24
K013773	Safe	Ssn Medical Products Sdn. Bhd.	HIS	Class II	2002-01-24
K013674	Luxatemp/luxatemp Solar/instatemp	Dmg USA, Inc.	EBG	Class II	2002-01-24
K013664	Coalescent Surgical U-Clip	Coalescent Surgical	NCA	Class II	2002-01-24
K013636	Signa Infinity Mr System with Excite Technology	GE Healthcare	LNH	Class II	2002-01-24
K013120	Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18	Greatbatch Medical	GZB	Class II	2002-01-24
K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	DQO	Class II	2002-01-24
K012534	Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating	Advanced Cardiovascular Systems, Inc.	DQX	Class II	2002-01-24
K011826	Eps320 Cardiac Stimulator	Micropace Pty. Ltd.	JOQ	Class II	2002-01-24
K011783	Multi-Snare Set	Pfm Produkte Fur die Medizin AG	DXE	Class II	2002-01-24
K011185	Psychemedics Ria Methamphetamine and Mdma Assay	Psychemedics Corp.	DJC	Class II	2002-01-24
K003889	Ancure Sheath Model # 40315, 40320, 40325	Guidant Cardiac and Vascular Surgery	DYB	Class II	2002-01-24
K020019	Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim)	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-01-23
K014224	Precision Plus Tuna Office System	Vidamed, Inc.	GEI	Class II	2002-01-23
K013558	Blackstone Spinal Fixation System 4.5Mm Mono-Axial Screw	Blackstone Medical, Inc.	KWQ	Class II	2002-01-23
K013555	Sci-Pharm Post Secure	Scientific Pharmaceuticals, Inc.	EMA	Class II	2002-01-23
K013303	Cleantexx Powderfree Synthetic Latex Examination Glove Made with Barrier-Pro Butadiene Co-Polmer	Latexx Manufacturing Sdn.Bhd.	LZA	Class I	2002-01-23
K012766	Portable Intensive Care Unit	Medical Research Laboratories, Inc.	MKJ	Class III	2002-01-23