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 , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| 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 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K002676 | Endovance Dualpass Tear-Away Sheath Introducer | Guidant Cardiac and Vascular Surgery | DYB | Class II | |
| K002356 | Natural-Knee II Patellofemoral Joint Prosthesis | Sulzer Orthopedics, Inc. | KRR | Class II | |
| K002325 | Wujin #3 Tibial Nail | Biologically Oriented Prostheses | JDS | Class II | |
| K002188 | Swissplus Implant System, Model Spwb 8,10,12,14/Oph20/smpr, Spb 8,10,12,14/Op3.5d/opar,opb 8,10,12,14/Op2.3d/op2.8d, | Core-Vent Corp. | DZE | Class II | |
| K002130 | Nir Biliary Stent | Medinol Ltd. | FGE | Class II | |
| K001408 | Ksea Vascular Fiberscopes | Karl Storz Endoscopy-America, Inc. | LYK | Class II | |
| K000861 | Craniocap | Gillette Children'S Specialty Healthcare | MVA | Class II | |
| K000638 | Responder 3000 | GE Medical Systems Information Technologies, Inc. | MKJ | Class III | |
| K000620 | Pbn Fallopian Tube Catheter System | Medical Device Technologies, Inc. | MDG | Class II | |
| K003076 | Mitek Cufftack | Mitek Products | MAI | Class II | |
| K003006 | Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection | Arrow Intl., Inc. | LJT | Class II | |
| K002424 | 3D Angiographic Imaging System, Model Xidf-100A | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K001972 | Argus System-Continuous Expert Care Network | Visicu, Inc. | MSX | Class II | |
| K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | ILY | Class II | |
| K000317 | Spectra-Vrm Q-Switched Nd:yag Laser System, Spectra-Vrm | Tissue Medical Lasers, Inc. | GEX | Class II | |
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ Filter | Gambro Healthcare | MSF | Class II | |
| K993101 | Liteaire | Thayer Medical Corportation | CAF | Class II | |
| K003232 | Rs Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile) | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K003194 | Stackhouse Lens Hood, Model Sa-700/Fs | Stackhouse, Inc. | FYA | Class II | |
| K002880 | 300Lc Ultrasound Imaging Systems, Model 300Lc | Pie Medical | IYN | Class II | |
| K002702 | Neurotology Drape, Model Tbd | Gyrus Ent LLC | KKX | Class II | |
| K002664 | Hardydisk Levofloxacin, 5Mcg | Hardy Diagnostics | JTN | Class II | |
| K002661 | Hardydisk Cefotetan, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K002660 | Hardydisk Lomefloxacin, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K002646 | Abx Micros Crp | Horiba Instruments Incorporated | GKZ | Class II | |
| K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads | Medivance Inc. | DWJ | Class II | |
| K002564 | Sheep Anti-Human Kappa Free Light Chain Immunofixation Grade Kit | The Binding Site | DFH | Class II | |
| K002563 | Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit | The Binding Site | DEH | Class II | |
| K002561 | Sheep Anti-Human Igd Immunofixation Grade Kit | The Binding Site | CZJ | Class II | |
| K002560 | Sheep Anti-Human Ige Immunofixation Grade Kit | The Binding Site | DGC | Class II | |
| K002531 | Excelart with Pianissimo, Model Mrt-1501/P3 | Toshiba America Mri, Inc. | LNH | Class II | |
| K002376 | Advia: Centaur and Acs: 180 Cpsa Assay | Bayer Corp. | LTJ | Class II | |
| K002369 | Hardydisk Gentamicin, 120Mcg | Hardy Diagnostics | JTN | Class II | |
| K002367 | Hardy Disk Ceftizoxime, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K002316 | Phoenix Digital EEG | Axon Systems, Inc. | GWQ | Class II | |
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp | Automatic Liquid Packaging, Inc. | JOL | Class II | |
| K003221 | Harald Nordin Glassix Glass Fiber Composite Dental Post | Harald Nordin S.A. | ELR | Class I | |
| K003219 | Harald Nordin Carbonite Carbon Fiber Composite Dental Post | Harald Nordin S.A. | ELR | Class I | |
| K003094 | Fastpack Psa Immunoassay, Fastpack Analyzer | Qualigen Inc | LTJ | Class II | |
| K003012 | Raichem Phosporus Reagent | Hemagen Diagnostics, Inc. | CEO | Class I | |
| K003004 | Oscar 2, Model 222 | Suntech Medical Instruments, Inc. | DXN | Class II | |
| K002982 | Olympus Au2700 Clinical Chemistry Analyzer | OLYMPUS Corporation of the Americas | JJE | Class I | |
| K002918 | Olympus Crp Latex Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | DCN | Class II | |
| K002675 | Millennium Edition 2000 Accelerated Electroforming System | Product Development Industries, Inc. | EJT | Class II | |
| K002656 | Hardydisk Cefuroxime, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K002558 | K-Assay High Sensitive Crp(2) for the Beckman Coulter Immage | Kamiya Biomedical Company, LLC | DCK | Class II | |
| K002522 | Opart, Model Mrt-600 | Toshiba America Mri, Inc. | MOS | Class II | |
| K002483 | Power 5000 General Purpose Coil | GE Healthcare Coils | MOS | Class II | |
| K002372 | Access Alert Gauge | Medisystems Corp. | KOC | Class II | |
| K002368 | Hardydisk Streptomycin, 300Mcg | Hardy Diagnostics | JTN | Class II |