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 |
|---|---|---|---|---|---|
| K010091 | EEG with Video, Model Ex-Nw | Excel Tech., Ltd. | GWQ | Class II | |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450 | A & A Medical, Inc. | LKF | Class II | |
| K010048 | M2376a Devicelink System | Agilent Technologies, Inc. | MWI | Class II | |
| K003930 | Flextime Magnum 360 | Kulzer GmbH | ELW | Class II | |
| K003840 | Crystal Vision #250D Smoke Evacuator System with Accessories | I.C. Medical, Inc. | FYD | Class II | |
| K003737 | Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (200 Microgramsper or Less) | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K003671 | Lambda Immage Freelite Kit | The Binding Site | DEH | Class II | |
| K003669 | Kappa Immage Freelite Kit | The Binding Site | DFH | Class II | |
| K003644 | Eyetect Tremor Monitor Unit (Tmu) | Eyetect, LLC | GWN | Class II | |
| K003615 | Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips | Environmental Test Systems, Inc. | FKP | Class II | |
| K003482 | Proclude-Sensitive | Ortek Therapeutics, Inc. | LBH | Class II | |
| K003461 | Bd Vacutainer Passive Shielding Blood Collection Needle | BD Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | |
| K003443 | Suction Irrigator | Applied Medical | FHF | Class II | |
| K003425 | Clirans E-Series Hollow Fiber Dialyzers | Terumo Medical Corp. | KDI | Class II | |
| K002688 | Personal Glucose Control Charting System | Lxn Corp. | CGA | Class II | |
| K002042 | Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018 | New England Medical Corp. | HGI | Class II | |
| K010003 | Ebi Vuelock Anterior Cervical Plate System | Ebi, LLC | KWQ | Class II | |
| K002822 | Vertex System | Medical Positioning Inc | DPS | Class II | |
| K002445 | Lifepak 12Defiberllator/monitor Series | Physio Control, Inc. | MKJ | Class III | |
| K010042 | CT Perfusion 2 | General Electric Co. | JAK | Class II | |
| K003394 | Appalead Gw+03xxxxxxr Series | Nipro Medical Corporation | DQX | Class II | |
| K002231 | Lf-Dp Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary Equipment | Olympus Optical Co., Ltd. | FDS | Class II | |
| K010078 | Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free) | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K003948 | Epi-Derm Silicone Gel Sheeting | Biodermis LLC | MDA | Class I | |
| K003693 | Direct Bilirubin | JAS Diagnostics/Drew Scientific | CIG | Class II | |
| K003577 | Steris Deepsite Fiber Optic Surgical Light | STERIS Corporation | FST | Class II | |
| K003519 | Yasargil Permanent Aneurysm Clips | Aesculap Inc | HCH | Class II | |
| K003467 | Chase Cardiovascular Patch | Chase Medical, Inc. | DXZ | Class II | |
| K003397 | Colles C Series Frame Sterile Pack | Depuy Orthopaedics Inc. | KTT | Class II | |
| K003380 | Bioteque Vaginal Dilator | Bioteque America Inc | HDX | Class II | |
| K002791 | Noninvasive Blood Pressure Measurement System | Unix Electronic Co., Ltd. | DXN | Class II | |
| K002338 | Liquiderm Liquid Adhesive Bandage | Closure Medical Corp. | KMF | Class I | |
| K002273 | Stockert A272 Series Pediatric Aortic Cannulae | Stoeckert Instrumente | DWF | Class II | |
| K001543 | Bpc-3000 Personal Blood Pressure Communicator, Model 52520 | Welch Allyn Inc | DXN | Class II | |
| K003375 | Control Male Condoms of Natural Rubber Latex | Tecnilatex S.A. | LTZ | Class II | |
| K010072 | Powder Free Purple Nitrile Examination Gloves, Nonsterile | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K010054 | Guthrie Shield Blue Latex Examination Gloves, Powdered with Protein Content Labeling Claim (200 Micrograms or Less) | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K003982 | Temperature Function, Model 9500 Multigas Monitor | Magnetic Resonance Equipment Corp. | CCK | Class II | |
| K003934 | Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) | Seltom Pacific Sdn. Bhd. | LYY | Class I | |
| K003917 | Modification to Fluorotex II Surgical Mesh | Bridger Biomed, Inc. | FTL | Class II | |
| K003906 | Modification to Flurotex Surgical Mesh | Bridger Biomed, Inc. | FTL | Class II | |
| K003748 | Tianxie | Suzhou Tianyi Acupuncture Instruments Co., Ltd. | MQX | Class II | |
| K003682 | Medcomp Z-Cath | Medical Components, Inc. | LJS | Class II | |
| K003670 | Patient Drape, Surgical | Advance Medical Designs Inc | KKX | Class II | |
| K003653 | Sterile Powder Free Polymer Coated Latex Examination Gloves, with Protein Labeling Claim (50 Microgram or Less) | WRP Asia Pacific Sdn Bhd | LYY | Class I | |
| K003409 | Elecsys Fsh Calset II | Roche Diagnostics GmbH | JIT | Class II | |
| K003407 | Systemp.desensitizer (Vivadent.desensitizer) | Ivoclar North America, Inc. | EMA | Class II | |
| K003055 | Medline Sterile Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | MEDLINE INDUSTRIES, LP - Northfield | LYY | Class I | |
| K002719 | Formula One Powdered Latex Examination Glove, with Protein Content Labeling Claim 200 Micrograms or Less and Made from a | Tillotson Healthcare Corp. | LYY | Class I | |
| K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | LOD | Class II |