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 |
|---|---|---|---|---|---|
| K001909 | Plainsense Wheelchair | Plainsense Wheelchairs, Inc. | IOR | Class I | |
| K001743 | Ultima Smartbelt, Model 0560 | Braebon Medical Corp. | BZQ | Class II | |
| K001681 | Positrace Dual Mode Pet/ct Oncology System | Smv America | KPS | Class II | |
| K000811 | Nlite System, Sls Model Number A00-1025 | Sls Biophile, Ltd. | GEX | Class II | |
| K000808 | Rich-Mar Winner St4 Muscle Stimulator, Interferential, and TENS Device | Rich-Mar Corp. | IPF | Class II | |
| K000356 | C.t.m. Mobility Scooter, Model H2-686, Hs-740, Hs-580 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K000354 | C.t.m. Mobility Scooters Hs-666, Hs-730, Hs-570 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K002435 | Modification to Axya Medical, Inc. Bone Anchor System and Kit (Bak) | TORNIER Inc. | GAW | Class II | |
| K002324 | Modified to Modular Fr Severe Bone Loss Trauma | Sulzermedica | JDI | Class II | |
| K002298 | Super 1 | Dental Alloy Products, Inc. | EJH | Class II | |
| K002206 | Hi-Torque Whisper Ls Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper Ms Guide Wire with Hydrocoat Hydro | Boston Scientific Corporation | DQX | Class II | |
| K002021 | Hemostatix Thermal Scalpel System - #12 Blade | Gyrus Ent LLC | GEI | Class II | |
| K001847 | Anterior Cervical Plate System | Encore Orthopedics, Inc. | KWQ | Class II | |
| K001759 | Hedrocel Revision Cup, Model 02-2Yy-Zzzz | Implex Corp. | JDI | Class II | |
| K001720 | Synthes Sacral Bar System | Synthes (USA) Products LLC | JDW | Class II | |
| K001666 | Modification to Intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | GCJ | Class II | |
| K001636 | C-Reactive Protein Antiserum Kit | The Binding Site | DCK | Class II | |
| K001633 | Lifesite Hemodialysis Access System/cannula Exchange, Model Lhas14120 & Lhcek0000 | Vasca, Inc. | MSD | Class II | |
| K001560 | Odontosurge 3 | Odonto-Wave | EKZ | Class II | |
| K000718 | Chromostreak | Novamed Co., Ltd. | JSN | Class I | |
| K000401 | Vapotherm, Model 2000I | Vapotherm Inc. | BTT | Class II | |
| K000158 | Veinlase, Model E50-K8-B5, Spectrum K8, Model E50-K8-B9 | Fisma, Inc. | GEX | Class II | |
| K993950 | Cecilia Penguin Multi-Use Thermometer, Model Hp-Eto9999 | Nien Made Electrnics Corp. | FLL | Class II | |
| K002434 | Palm Pump | Sorenson Medical, Inc. | MEA | Class II | |
| K002240 | Render-Plan 3-D 4.00 & Precise-Plan 1.0 | Precision Therapy Intl., Inc. | MUJ | Class II | |
| K001943 | Chronalco I.d.cdt (Carbohydrate Deficient Transferrin) Assay | Sangui Biotech, Inc. | NAO | Class I | |
| K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories | GE Healthcare | CCK | Class II | |
| K000859 | Office Based Anesthesia Machine, Model Oba-1 | Charles A. Smith | BSZ | Class II | |
| K000355 | 3M Comply 1249 Liquid Peracetic Acid Chemical Indicator | Minnesota Mining and Mfg. Co. | JOJ | Class II | |
| K002340 | Vinyl Examination Glove, Powder-Free, Yellow | Glormed Intl., Inc. | LYZ | Class I | |
| K002238 | Capiox Sx Hardshell Reservoir with X-Coating | Terumo Cardiovascular Systems Corporation | DTN | Class II | |
| K002223 | Epic Spo2 Finger Sensor, Model E412-20 | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K002174 | Document Assayed Chemistry Control, Levels 1, 2 And3 | Casco-Nerl Diagnostics Corporation (Maine) | JJY | Class I | |
| K002148 | Elecsys Hcg Test System | Roche Diagnostics GmbH | DHA | Class II | |
| K002065 | Patient Latex Polymer Coated Powder-Free Gloves, Contains 50 Microgram or Less of Total Water Extractable Protein per Gr | Comfort Rubber Gloves Industries Sdn Bhd | LYY | Class I | |
| K001935 | Access Testosterone Reagents for Use on the Access Immunoassay Analyzer, Models 33560, 33565 | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K001881 | Improved Enlight Lv | Sybron Dental Specialties, Inc. | DYH | Class II | |
| K001740 | Ksea Monopolar Vaporization Electrodes | Karl Storz Endoscopy-America, Inc. | HIH | Class II | |
| K001598 | Biobar, Implantable Biodegradable Collagen Membrane for Guided Bone Regeneration | Col-Bar, Ltd. | LYC | Class II | |
| K000969 | Microlife Digital Infrared Ear Thermometer, Model Ir1da1 | Microlife Corp. | FLL | Class II | |
| K000475 | Brachyseed | Draximage, Inc. | KXK | Class II | |
| K002120 | Liquichek Blood Gas Control, Model 571, 572, 573 | Bio-Rad | JJS | Class I | |
| K001981 | Diastat Anti-Cardiolipin Iga, Model Fcar 500 | Axis-Shield, Ltd. | MID | Class II | |
| K001875 | Diamedix Is-Rubella Igm Capture Test System | Diamedix Corp. | LFX | Class II | |
| K001683 | Sysmex R-500 | Sysmex Corporation of America | GKL | Class II | |
| K001556 | Hep-2 Ana Test System with If-Aim Technology | The Binding Site | DHN | Class II | |
| K001462 | Careside Hemoglobin | Careside, Inc. | KHG | Class II | |
| K001411 | Whole Pth (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3Kg056 | Scantibodies Laboratory Inc. | CEW | Class II | |
| K001392 | Glycosal Hba1c Test | Provalis Diagnostics, Ltd. | LCP | Class II | |
| K993409 | Remed Male Tutti Frutti Condom (Coconut) Preventor, Lucky Boy, Summit | Remed Pharma | HIS | Class II |