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 |
|---|---|---|---|---|---|
| K012953 | Giotto Image | Medx, Inc. | IZH | Class II | |
| K012582 | Ameditech Immutest Drug Screen Pcp | Ameditech, Inc. | LCM | Unclassified | |
| K012521 | Binax Now Streptococcus Pneumoniae Test | Binax, Inc. | GTZ | Class I | |
| K012484 | Ameditech Immutest Drug Screen Amphetamine | Ameditech, Inc. | DKZ | Class II | |
| K012483 | Ameditech Immutest Drug Screen Opiates | Ameditech, Inc. | DJG | Class II | |
| K012115 | Serim Blood Leak Test Strip-2 | Serim Research Corp. | FJD | Class II | |
| K011684 | Influenza A/b Rapid Test, Cat No 2158 663 | Roche Diagnostics GmbH | PSZ | Class II | |
| K011479 | One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System | Inverness Medical Innovations, Inc. | CGA | Class II | |
| K011043 | Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) | Opti Medical Systems Inc | JXA | Class I | |
| K013845 | Modification to: Mac-Line O2/co2 Oral Nasal Cannula Sample Line | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K013489 | Kp + Lfm | Pds Healthcare Products, Inc. | BZH | Class II | |
| K013443 | Powdered Latex Medical Medical Examination Gloves with 150 Micrograms or Less of Total Water Extractable Protein per Dm2 | Maxter Glove Manufacturing Sdn Bhd | LYY | Class I | |
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040G | IMMUNO CONCEPTS, NA, Ltd. | KTL | Class II | |
| K013427 | Modification To:philips M3000a/m3046a Compact Portable Patient Monitor, Models Philips M3000a/m3046a | Philips North America LLC | MHX | Class II | |
| K013324 | Hpi Sensi Grip Sterile Powdered Latex Surgical Glove,with Labeled Protein Content and Made from Allotex an Enzyme Treat | Tillotson Healthcare Corp. | KGO | Class I | |
| K013264 | Micro Stamping Ligating Clip | Micro Stamping Corporation | FZP | Class II | |
| K013261 | Motex Nitrile Examination Gloves Powder-Free | Shanghai Motex Healthcare Co., Ltd. | LZA | Class I | |
| K013117 | Resection Ablator | Linvatec Corporation | HRX | Class II | |
| K013049 | Norad, Nocturnal Oral Airway Dilator Appliance | Dennis R. Bailey, Dds | LRK | Class II | |
| K012991 | Neptune Waste Management Ststem | Stryker Corp. | FYD | Class II | |
| K012941 | Drystar, Model 4500M | Agfa Corp. | LMC | Class II | |
| K012361 | Tina-Quant Complement C3c Test System | Roche Diagnostics GmbH | CZW | Class II | |
| K012359 | Tina-Quant Complement C4 Test System | Roche Diagnostics GmbH | DBI | Class II | |
| K011308 | Multistim | Pajunk GmbH Medizintechnologie | BXN | Class II | |
| K001121 | Oxygen Applied Symptom Improvement System (Oasis) | Engineered Medical Technology, Inc. | CBF | Class II | |
| K013696 | Silmed Nasal Septal Button | Silmed, Inc. | LFB | Unclassified | |
| K013682 | Modification to Basic Dental Implant System | Basic Dental Implant Systems, Inc. | DZE | Class II | |
| K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | DQY | Class II | |
| K013472 | Total O2 | Chad Therapeutics, Inc. | CAW | Class II | |
| K013199 | Philips Component Compact Monitor,model M1275b, Philips Compenent Rack, Model M1276b | Philips North America LLC | MHX | Class II | |
| K013185 | Tcm Endo III | Nouvag AG | EFA | Class I | |
| K012920 | Molded Cranial Helmet | Fairview Orthopedic Laboratory | MVA | Class II | |
| K012917 | Dynarex Umbilical Cord Lamp, Models 6833 and 6833-B | Dynarex Corp. | HFW | Class II | |
| K012908 | Bioplate Resorbable Bone Screw | Bioplate Inc | DZL | Class II | |
| K011909 | Ultra-Thin Sds Balloon Dilatation Catheter | Boston Scientific Corporation | FGE | Class II | |
| K010607 | Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001 | Canadian Hospital Specialties Ltd. | LJH | Class II | |
| K010366 | Disposable Storage Cap | Molded Products Inc | FJI | Class II | |
| K013810 | Cardiovascular Array | W. L. Gore & Associates, Inc. | MOS | Class II | |
| K013731 | Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha Bronchoscopes Model # E.8189.00/01/02/03 | Gimmi GmbH | EOQ | Class II | |
| K013266 | Rusch Polyflex Stent Kit | Rusch Intl. | NYT | Class II | |
| K013145 | Wiener Lab. Got (Ast) UV Aa. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 Ml Cat. Nr. 1751302 and 20 * 2 Ml Cat Nr. | Wiener Laboratories Saic | CIT | Class II | |
| K012918 | Apex Modular Alumina Femoral Head | VQ Orthocare | LZO | Class II | |
| K012916 | Frontier Anterior Scoliosis System | Depuy Acromed, Inc. | KWQ | Class II | |
| K012516 | Ebi Spinelink - II Spinal Fixation System | Ebi, LLC | KWP | Class II | |
| K012070 | Orallite Comprehensive Exam Tray | Trylon Corp. | MPU | Class II | |
| K010771 | Periolase Nd:yag Dental Laser System | Millennium Dental Technologies, Inc. | GEX | Class II | |
| K013796 | Livesure Methadone Screen Tests | Pan Probe Biotech, Inc. | DJR | Class II | |
| K013711 | Bacti-Swab Dry | Remel Inc | LIO | Class I | |
| K013180 | Rapidone-Ecstasy Test | American Bio Medica Corp. | DJC | Class II | |
| K013136 | Aneurysm Clips | Gistlstrasse | HCH | Class II |