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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 857 of 3530

510(k) clearances, page 857 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122310	Geminus Fossa Specific Plate System	Skeletal Dynamics, Inc	HRS	Class II	2013-01-18
K121762	Cardiac Vx	GE Healthcare	LLZ	Class II	2013-01-18
K121739	Ivue with Normative Database	Optovue Inc.	HLI	Class II	2013-01-18
K121592	Powder Free Blue Nitrile Examination Glove Tested with Chemotherapy Drugs	Tekmedic (M) Sdn Bhd	LZA	Class I	2013-01-18
K120464	Innesis Peek Cage	BK Meditech Co., Ltd.	MAX	Class II	2013-01-18
K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-ENT Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe	Med-Fibers, Inc.	GEX	Class II	2013-01-17
K123946	Warmair Model 135 Hyperthermia System Including Filteredflo Blankets	Gentherm Medical, LLC	DWJ	Class II	2013-01-17
K123734	Bd Nexiva Diffusics Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2013-01-17
K123612	Fdi Glucose Control Solution for Use with Accu-Chek Aviva	Fujirebio Diagnostics, Inc.	JJX	Class I	2013-01-17
K123417	Brivo Mr355, Optima Mr360	GE Hangwei Medical Systems, Co. Ltd	LNH	Class II	2013-01-17
K123110	Pretzelflex Surgical Retractor Model Shr7301	Surgical Innovations Ltd	GCJ	Class II	2013-01-17
K122951	Xoft Axxent Electronic Brachytherapy System Model 110	iCAD, Inc.	JAD	Class II	2013-01-17
K122788	Textured, Natural to Off-White, Latex, Sterile, Powder Free Examination Gloves, with Protein Labeling Claim (50 Ug/dm2 O	Northstar Healthcare Holdings	LYY	Class I	2013-01-17
K122585	Crux Vena Cava Filter System	Crux Biomedical	DTK	Class II	2013-01-17
K122408	Powder Free Nitrile Examination Gloves (Black, White, Green)	Hongye Plastic Products Co., Ltd.	LZA	Class I	2013-01-17
K122132	Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam	Molnlycke Health Care	OMP	Class II	2013-01-17
K121929	Zephyr 'X-Series Patient Transfer Sled	Diacor, Inc.	FRZ	Class II	2013-01-17
K121606	Resorb-X G	KLS-Martin L.P.	GWO	Class II	2013-01-17
K121421	Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)	Fresenius Medical Care North America, Design Cente	ONW	Class II	2013-01-17
K121098	Hero I Dental Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2013-01-17
K102689	Conventus Orthopaedics Fracture Fixation System	Conventus Orthopaedics, Inc.	HRS	Class II	2013-01-17
K123922	Syngo Dynamics	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2013-01-16
K123838	Pro Hmpv+ Assay	Gen-Probe Prodesse, Inc.	OEM	Class II	2013-01-16
K123671	Wellaho Personalized Outpatient Management System	Sanitas, Inc.	DRG	Class II	2013-01-16
K123609	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2013-01-16
K123274	Progastro Sscs Assay	Gen-Probe Prodesse, Inc.	PCH	Class II	2013-01-16
K123264	Dk-Ptca Balloon Catheter	Intuit Medical, LLC	LOX	Class II	2013-01-16
K123038	Swiss Lithobreaker	E.M.S. - Electro Medical Systems SA	FFK	Class II	2013-01-16
K121570	Auriga Qi	Starmedtec GmbH	GEX	Class II	2013-01-16
K121392	Novation Crown Cup Liners; Neutral, Lipped, +5Mm Lateralized, +5/10 Degree	Exactech, Inc.	LZO	Class II	2013-01-16
K113246	Ocs-B	Nibec Co., Ltd.	NPM	Class II	2013-01-16
K123878	Prevena Incision Management System with Customizable Dressing	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2013-01-15
K123788	Integrated Collimator Verification and Interlock System (Icvi)	Varian Medical Systems, Inc.	IYE	Class II	2013-01-15
K123535	Ilab Ultrasound Imaging System	Boston Scientific Corporation	IYO	Class II	2013-01-15
K123408	Ergo Imaging System	Digirad Corp.	IYX	Class I	2013-01-15
K123004	Mira Lasers	Mira Lasers, LLC	GEX	Class II	2013-01-15
K122873	Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model Sqs	Caremed Supply, Inc.	JOW	Class II	2013-01-15
K123905	Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel	Centers for Disease Control and Prevention	OQW	Class II	2013-01-14
K123898	Volcano S5/s5i Intravascular Ultrasound Imaging and Pressure System	Volcano Corporation	IYO	Class II	2013-01-14
K123752	Acculif Tl and Pl Cage	Coalign Innovations, Inc.	MAX	Class II	2013-01-14
K123372	Abbott Lipid Multi Constituent Calibrator	Abbott Medical	JIX	Class II	2013-01-14
K123311	Qxmedical Access & Support Catheter	Qxmedical, LLC	DQY	Class II	2013-01-14
K122870	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2013-01-14
K122708	Remesense for Sensitive Teeth	Sylphar N.V.	LBH	Class II	2013-01-14
K121706	Fora V10 Blood Glucose Monitoring System	Foracare, Inc.	CGA	Class II	2013-01-14
DEN130003	Xtag Gastrointestinal Pathogen Panel (Gpp) Xtag Data Analysis Software for Gpp (Tdas)	Luminex Molecular Diagnostics Inc	PCH	Class II	2013-01-14
K123839	Wa Series: Wa100; Wa200; Wd100; We100, Wf100; Wb200	Ningbo Diaier Electronic Co., Ltd.	DXN	Class II	2013-01-11
K123644	Vizion + Dr	Viztek, LLC	MQB	Class II	2013-01-11
K123414	Specboard Jr.	Macbrud Corp., Medical Division	IZH	Class II	2013-01-11
K123327	1.5T Gem Rt Open Array	GE Healthcare Coils (USA Instruments, Inc.)	MOS	Class II	2013-01-11