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 |
|---|---|---|---|---|---|
| K003233 | Rs Nitrilstst Medical Examination Gloves, Powdered (Non Sterile) Blue | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K003222 | Modification to Hermes Operating Room Control Center | Computer Motion, Inc. | GCI | Class II | |
| K003217 | Hermes Port Expander | Computer Motion, Inc. | GCJ | Class II | |
| K003019 | Profeel Powder Free Polymer Coated Neoprene Surgical Gloves Sterile | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K002924 | 3D Endoscope | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K002704 | Ksea Miniature Neuroendoscope | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K002582 | Pilling E-Frazier Bipolar Suction Tube | Pilling Co. | GEI | Class II | |
| K002509 | Novalis (Shaped Beam Surgery System) | Brainlab, Inc. | MUJ | Class II | |
| K002421 | Candela Mid Ir Diode Laser System | Candela Corporation | GEX | Class II | |
| K002398 | Endopath Ets45, Ets Flex45, Ets Compact-Flex45 Linear Cutters, Ets Flex45 and Ets Compact-Flex45 No-Knife Articulating | Ethicon Endo-Surgery Inc | OCW | Class II | |
| K001788 | Estation Electronic Stethoscope, Model Dr200 | Erecords Enterprises | DQD | Class II | |
| K001714 | Mercury Medical Hyperinflation Bag System, Model 83-900-0149 | Mercury Medical | NHK | Class II | |
| K001347 | Meridian-II and Merdian-Plus | Meridian AG | GZO | Class II | |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60 | Hudson Respiratory Care, Inc. | BTT | Class II | |
| K001044 | Acme Spine System - Series 6000, 7000, Monoaxial and Polyaxial Screw System | Acme Spine, LLC | MNH | Class II | |
| K003236 | Retinadx | Regulatory Associates, Inc. | HKI | Class II | |
| K003131 | Modification to: Radiolucent Colles Fracture Kit | Zimmer GmbH | JDW | Class II | |
| K003112 | Vitros Immunodiagnostic Products Anti-Hbs Controls | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | |
| K002872 | R&d Project Dw271#11a | Ivoclar North America, Inc. | EJT | Class II | |
| K002662 | Hardydisk Clindamycin, 2Mcg | Hardy Diagnostics | JTN | Class II | |
| K002456 | Microtainer Brand Sodium Fluoride/edta Tube with Microgard Closure, Model 365992 | Becton Dickinson Vacutainer Systems | JKA | Class II | |
| K002392 | Ventrix True Tech Ventricular Tunneling Pressure Monitoring Kit, Model Nl960-V | Integra Neurocare, LLC | GWM | Class II | |
| K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401h | Lsi Intl., Inc. | JFB | Class II | |
| K002103 | Simplicity Spinal System | Medtronic Sofamor Danek USA Inc | KWP | Class II | |
| K001676 | Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210, 1210-Vhp, 1500-a | Trimedyne, Inc. | GEX | Class II | |
| K001455 | Accuwell Tsh, Model Kaw-Tsh-960 | Neometrics, Inc. | JLW | Class II | |
| K001249 | Qualitrol Dhp Immunoassay Control, Levels 1,2, and 3 | Consolidated Technologies of Wisconsin | JJY | Class I | |
| K991783 | Ab-180 Xc System, Model Ab-180Xc | Cardiacassist, Inc. | KFM | Class II | |
| K003282 | Full Auto Blood Pressure Monitor, Model Se-7700H | Sein Electronics Co., Ltd. | DXN | Class II | |
| K003114 | Numed Tyshak and Z-Med Ptv Catheters | NuMED, Inc. | LIT | Class II | |
| K003052 | Numed Tyshak II and Z-Med II Ptv Catheters | NuMED, Inc. | LIT | Class II | |
| K002374 | Iti Dental Implant System Monotype Implant | Straumann USA, LLC | DZE | Class II | |
| K002363 | Medovations Esophageal Dilator | Medovations, Inc. | KNQ | Class II | |
| K002362 | Synthes Calcium Sulfate Bone Void Filler Pellets (Synthes Pellets) | Synthes (USA) Products LLC | MQV | Class II | |
| K001948 | Cvprofilor D0-2020 Cardiovascular Profiling System | Hypertension Diagnostics, Inc. | DXN | Class II | |
| K003214 | Smith & Nephew Pistons | Gyrus Ent LLC | ETB | Class II | |
| K003065 | Seednet, Model Ep6t5, Ep5e5 | Galil Medical Ltd. | GEH | Class II | |
| K003060 | Plasmakinetic Generator | Everest Medical Corp. | GEI | Class II | |
| K002811 | Ana 70 Non Gamma 2 Dispersed Phase Dental Alloy | Nordiska Dental AB | EJJ | Class II | |
| K002810 | Ana 3000 Sm Non Gamma 2 Modified Spherical Dental Alloy | Nordiska Dental AB | EJJ | Class II | |
| K002808 | Ana 2000 Non Gamma 2 Extra High Copper Dental Alloy | Nordiska Dental AB | EJJ | Class II | |
| K002715 | Ecat Pet Scanner | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K002611 | Signa Mfo/i Magnetic Resonance System | GE Healthcare | LNH | Class II | |
| K002590 | Cedara Cardiology Viewer, Cardiology Archive Viewer, Cardiology Cd Viewer | Cedara Software Corp. | LLZ | Class II | |
| K002556 | Ceeon Easysert Intraocular Lens Injector, Model Imp-1 | Pharmacia & Upjohn Company LLC | MSS | Class I | |
| K002546 | Civ-Flex Holster Cover, Model Sterile, Latex-Free | CIVCO Medical Instruments Co., Inc. | KNW | Class II | |
| K002361 | Synthes (USA) Locking Proximal Plating (L-Ptp) System | Synthes (USA) Products LLC | HRS | Class II | |
| K002025 | Rigid Gas Permeable Contact Lens | Polymer Technology Corp. | HQD | Class II | |
| K003159 | Cordis Slalom Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K003061 | Synthes Uss (10.0Mm Side Opening Screws) | Synthes GmbH | KWQ | Class II |