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 |
|---|---|---|---|---|---|
| K003324 | Plasma Sprayed Shoulder | Encore Orthopedics, Inc. | KWS | Class II | |
| K013818 | Autogenesis Automator, Model M1000 | Autogenesis, Inc. | JEC | Class II | |
| K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp | MNH | Class II | |
| K013676 | Trident Hemispherical Acetabular Shells | Howmedica Osteonics Corp | MEH | Class II | |
| K013663 | Cement Restrictor | Medtronic Sofamor Danek | JDK | Class II | |
| K013660 | Genetra | Radiomed Corporation | KXK | Class II | |
| K013658 | Modification to Reflection Cross-Linked Uhmwpe Acetabular Components | Smith & Nephew, Inc. | LPH | Class II | |
| K013630 | Isite Radiology | Philips North America LLC | LLZ | Class II | |
| K013323 | Tci-31 Lifelong Ovulation Tester | Tci New York | CEP | Class I | |
| K013211 | Modification to: Acumatch L-Series Bipolar Endoprosthesis | Exactech, Inc. | KWY | Class II | |
| K013112 | Focal Sim | Elekta Limited | MUJ | Class II | |
| K013000 | Medtronic Invisx Burr Hole Lock, Model 60520 | Medtronic Neurosurgery | GXN | Class II | |
| K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469 | Baxter Healthcare Corporation | FKX | Class II | |
| K012324 | Accu-Chek Active Test System | Roche Diagnostics GmbH | NBW | Class II | |
| K012014 | Modification to Blood Glucose Monitoring System | Abbott Medical | NBW | Class II | |
| K013638 | Modification to Viking Optima Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K013024 | Selectiva Guidewire | Neometrics, Inc. | DQX | Class II | |
| K013013 | Medtronic Dlp Arterial Cannula with 3D Tip - 22 Fr. | Medtronic Cardiac Surgical Products | DWF | Class II | |
| K011958 | Crp-Latex (II) Seiken High Sensitivity Assay Kit | Denka Seiken'S | DCN | Class II | |
| K011845 | Millcomp | Math Resolutions, LLC | IYE | Class II | |
| K011393 | Randox Phenytoin | Randox Laboratories, Limited | DIP | Class II | |
| K002113 | Ctxa Hip; Ctxa; Qct Pro Ctxa Hip | Mindways Software, Inc. | KGI | Class II | |
| K013928 | Pain Care 3200 | Breg, Inc. | MEB | Class II | |
| K013849 | Tetrad Model Tc-Ec7-Acp, -L5-, -L7-, -V4-Acp Transducers | Tetrad Corp. | ITX | Class II | |
| K013772 | Modification to Hoffmann II Micro External Fixation System | Howmedica Osteonics Corp | LXT | Class II | |
| K013661 | Xplan 2.2 with the Body System | Radionics, A Division of Tyco Healthcare Group LP | MUJ | Class II | |
| K013657 | Modification to: Biomet Humeral Cable Plates | Biomet Orthopedics, Inc. | HRS | Class II | |
| K013624 | Modification to Agilent Component Monitoring System (Cms), V24/v26 Patient Monitors, Blood Analysis Portal System Plug-I | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K013502 | Simplicity Classic Wing Qd Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K013413 | Micromark II Tissue Marker,model C1535 | Ethicon Endo-Surgery Inc | NEU | Class II | |
| K013328 | Remington Paraffin Spa, Models Hs-200. Pfs-600 | Remington Products Company LLC | IMC | Class II | |
| K013288 | Non-Sterile Powder Free Green Latex Examination Gloves with Aloe Vera and Vitamin E | Sgmp Co., Ltd. | LYY | Class I | |
| K013287 | Nipro Safelet Cath | Nipro Medical Corporation | FOZ | Class II | |
| K013231 | Avid-Nit Plastic Hub Lutz Epidural Needle,model Rp2035l, Avid-Nit Metal Hub Lutz Epidural Needle, Model Rm2035l | Avid N.I.T., Inc. | BSP | Class II | |
| K013044 | Synthes 3.9 Mm Pelvic Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K012968 | Applied Access Seal | Applied Medical Resources Corp | GCJ | Class II | |
| K012945 | Synthes 2.4 Mm Cannulated Screw | Synthes (USA) Products LLC | HWC | Class II | |
| K012572 | Soft Tissue Screw and Washer | Zimmer GmbH | HWC | Class II | |
| K012469 | Resorbable No Profile Screw and Washer | Biomet Manufacturing Corp | HWC | Class II | |
| K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,virtual Fluoroscopy | Stryker Leibinger | HAW | Class II | |
| K012268 | Trimax | Standard Textile Co., Inc. | FYA | Class II | |
| K012258 | Companion Model 221, 321, 421 | Golden Technologies, Inc | INI | Class II | |
| K012071 | ENT Laservision | Union Medical USA | GEX | Class II | |
| K012025 | Macropore Surgiwrap (Ts) | Macropore Biosurgery, Inc. | FTL | Class II | |
| K011500 | Mentor Contour Profile Tissue Expander | Mentor | LCJ | Unclassified | |
| K011144 | Lifepak 600 Automated External Defibrillator | Physio Control, Inc. | MKJ | Class III | |
| K010166 | Imagyn Isosleeve / Isostar Needle System | Imagyn Medical Technologies, Inc. | IWJ | Class I | |
| K013536 | Emtrac; Delphin; Semtrac 2000 Set | Gynetics Medical Products NV | MQF | Class II | |
| K013501 | Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B | Gynetics Medical Products NV | MQF | Class II | |
| K013331 | Lympha Press Plus Device | Mego Afek | JOW | Class II |