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 |
|---|---|---|---|---|---|
| K002426 | The Bioplate Regid Fixation Bone Plating System for Cranomaxillofacial Surgery | Bioplate Inc | JEY | Class II | |
| K002375 | Stc Cannabinoids Intercept Micro-Plate Eia, Model 1118I | OraSure Technologies, Inc. | LDJ | Class II | |
| K004013 | Implex Continuum Knee System-Patellar Components, Model 04-Xx-Yyyyy | Implex Corp. | JWH | Class II | |
| K004007 | Dr180+oxy | North East Monitoring, Inc. | DSH | Class II | |
| K003941 | Elecsys Hcg Stat Claset II | Roche Diagnostics GmbH | JIS | Class II | |
| K003696 | Stratus Cs Stat Fluorometric Analyzer Bhcg Testpak,test System, Model Cbhcg, Bhcg Calpak,model Cbhcg-C, Bhcg Dilpak, Mod | Siemens Healthcare Diagnostics Inc. | DHA | Class II | |
| K003690 | Hardydisk Sulfisoxazole | Hardy Diagnostics | JTN | Class II | |
| K003576 | Q-Tel Rms (Rehabilitation Management System), Model 000503 | Quinton, Inc. | DSI | Class II | |
| K003541 | Denlaser, Model 800 | Cao Group, Inc. | GEX | Class II | |
| K003460 | Palomar Clear Light Nd: Yag Laser System | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K003392 | Cardio Monitor Center Vision; Model S-Cv7-00 | SHL TeleMedicine International | DPS | Class II | |
| K003385 | Twilite, Twilite White | Biolase MG LLC | GEX | Class II | |
| K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn Inc | HLI | Class II | |
| K003250 | Fmp Metal/metal Acetabular Insert | Encore Orthopedics, Inc. | KWA | Class III | |
| K002007 | Sulzer Vascutek Gelsoft Ers Vascular Prosthesis | Sulzer Carbomedics, Inc. | DSY | Class II | |
| K001985 | Introdeuce Double Lumen Introducer | Cook Inc. | DYB | Class II | |
| K001961 | Stockert A242 and A252 Series Arterial Femoral Cannulae | Stoeckert Instrumente | DWF | Class II | |
| K001678 | Pva Foam Embolization Particles | Surgica Corp. | HCG | Class II | |
| K001624 | Gebauer's Fluori-Methane, Model 0386-0003-04 | Gebauer Co | MLY | Unclassified | |
| K994060 | The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate | Bioplate Inc | JEY | Class II | |
| K991618 | Bi-O.k. Self-Contained Biological Indicator | Propper Mfg Co Inc | FRC | Class II | |
| K010038 | Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field Drape | Cambridge Marketing, Inc. | FMI | Class II | |
| K010034 | Double Lumen Urethane Picc Line, Model Upicds- | Cook Inc. | FOZ | Class II | |
| K004027 | Stryker Remote Surgical Planning System | Stryker Corp. | HAW | Class II | |
| K003997 | Intrastent Doublestrut Paramount Xs Biliary Endoprosthesis | Intratherapeutics, Inc. | FGE | Class II | |
| K003990 | Sofradim Parietex Surgical Meshes | Sofradim Production | FTL | Class II | |
| K003921 | Dyract Cem Lci Compomer | Dentsply Intl. | EMA | Class II | |
| K003904 | Polymer Coated Powder Free Latex Examination Gloves | Purna Bina Sdn Bhd | LYY | Class I | |
| K003511 | Kendall-Ltp Turner Save-a-Line | The Ludlow Company LP | FRP | Class I | |
| K003487 | Stimate N601 TENS | Everyway Medical Instruments Co., Ltd. | GZJ | Class II | |
| K003427 | Zinc Phosphate Cement | Rite-Dent Manufacturing Corp. | EMA | Class II | |
| K003351 | Parsfix Cable-Screw System | Spinal Concepts, Inc. | KWP | Class II | |
| K010060 | Rita Starburst Xli Electrosurgical Device | Boston Scientific Corporation | GEI | Class II | |
| K003883 | Molina Orbital Malar Distractor | KLS-Martin L.P. | JEY | Class II | |
| K003872 | Guthrie Prime Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K003791 | Cavex Temporary Cement | Cavex Holland B.V. | EMA | Class II | |
| K003639 | Vitrea 2 CT Perfusion Option | Canon Medical Informatics, Inc. | JAK | Class II | |
| K003628 | Magnetom Rhapsody System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K003573 | Diffusion Tensor Imaging Option | GE Healthcare | LNH | Class II | |
| K003426 | Alginate Impression Material | Rite-Dent Manufacturing Corp. | ELW | Class II | |
| K002968 | Medline Sterilization Wrap | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K002236 | Horizons Papillotome | Horizons Intl. Corp. | KNS | Class II | |
| K002235 | Horizons Ercp Cannula | Horizons Intl. Corp. | FGE | Class II | |
| K010002 | Contour Polaris Ureteral Stent | Boston Scientific Corporation | FAD | Class II | |
| K003959 | Quanta Lite Centromere (Cenp-a & Cenp-B) Elisa | Inova Diagnostics, Inc. | LJM | Class II | |
| K003708 | Advantage Thc/cocaine Test | Advantage Diagnostics Corp. | DIO | Class II | |
| K003688 | View Reading Station | Electromed Intl., Ltd. | LLZ | Class II | |
| K003579 | Narkomed MRI-2, Model Nm-MRI-2 | Draeger, Inc. | BSZ | Class II | |
| K003459 | Philips Easy Vision Family Workstation Option Mr Quantitative Flow | Philips North America LLC | LLZ | Class II | |
| K003342 | Wako Crp-Ul, Crp-Ul Calibrator Set | FUJIFILM Healthcare Americas Corporation | DCN | Class II |