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 |
|---|---|---|---|---|---|
| K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | DZE | Class II | |
| K022711 | Modification to Avalon Cup System | Orthopedic Source, Inc. | LPH | Class II | |
| K022601 | Powder-Free Latex Examination Glove (Surface Treated with Aloe Vera Gel) | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K022555 | Accolade C Femoral Stems | Howmedica Osteonics Corp | LZO | Class II | |
| K022531 | 2Mm Pediatric Flex Nail | Zimmer GmbH | HTY | Class II | |
| K022530 | Powdered Latex Exam Gloves with Protein Labeling (200Ug/g or Less) | Hycare Intl. Co., Ltd. | LYY | Class I | |
| K022511 | Aart Calf Implant | Aesthetic and Reconstructive Technologies, Inc. | MIB | Class II | |
| K022481 | S2 Tibial Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K022330 | Allgrad 45 and 90 Cell Separation Media | <Genx> Intl., Inc. | MQL | Class II | |
| K021947 | Ceranum 87 | Lucius Metals Com. | EJT | Class II | |
| K021933 | Tempfix External Fixation System | Depuy Orthopaedics Inc. | KTT | Class II | |
| K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K021786 | Titanium Ankle Arthrodesis Nail | Zimmer GmbH | HSB | Class II | |
| K021782 | Bnf | AAP Implantate AG | JDS | Class II | |
| K021777 | Gyrus ENT Cogent 2/G2 System (Generator,accessories Somnoplasty Electrodes and Plasmacision Electrodes) | Gyrus Ent LLC | GEI | Class II | |
| K021737 | Rephresh Vaginal Gel | Columbia Laboratories, Inc. | NUC | Class II | |
| K020529 | Large Centrifugal Blood Pump, Model Cp-2 | A-Med Systems, Inc. | KFM | Class II | |
| K022689 | Modification to Medamicus Axia Rsn | Greatbatch Medical | DYB | Class II | |
| K022578 | Endius Flextip Blade | Endius, Inc. | HRX | Class II | |
| K022561 | Catheter Repair Kit with Replacement Connector, Model 5587000 | C.R. Bard Inc | NFK | Class II | |
| K022554 | Monitorr Icp External Csf Drainage and Monitoring System | Integra NeuroSciences | JXG | Class II | |
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25 | Diagnostic Chemicals, Ltd. (USA) | JIR | Class I | |
| K022507 | Datex-Ohmeda S/5 Network and Central '02 | GE Healthcare | MSX | Class II | |
| K022488 | Model Obc-63 Breast Array Coil | Mri Devices Corp. | MOS | Class II | |
| K022487 | Model Exs-63-Int Small Extremity Array Coil | Mri Devices Corp. | MOS | Class II | |
| K022437 | Uni Knee | Encore Medical, LP | HRY | Class II | |
| K022350 | Bard Crurasoft Patch, Models 0116003 & 0116001 | C.R. Bard Inc | FTL | Class II | |
| K022335 | Allgrad and Allgrad100 | <Genx> Intl., Inc. | MQL | Class II | |
| K022332 | Lite Mineral Oil | <Genx> Intl., Inc. | MQL | Class II | |
| K022239 | Surgetics Entact Endonasal Navigation System | Praxim S.A | JAK | Class II | |
| K022072 | Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents | Precision Systems, Inc. | CIX | Class II | |
| K022044 | Surgisis Staple Line Reinforcement | Cook Biotech, Inc. | OXE | Class II | |
| K021996 | Bolton Pta Catheter | Bolton Medical Inc. | LIT | Class II | |
| K021986 | Brainet | Nicolet Biomedical, Inc. | GXY | Class II | |
| K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K021762 | Bclear | Lumenis Ltd | FTC | Class II | |
| K021062 | Chito-Seal | Abbott Vascular | QSY | Unclassified | |
| K020768 | 3T Vessel Cannulas | 3T Medical Systems Inc. | DWF | Class II | |
| K020400 | Digitimer D185 Multipulse Cortical Stimulator | Meps, LLC | GWF | Class II | |
| K020220 | Ultrasonic Straight/ultrasonic Knife/ultrasonic Ring Currette | Synergetics Inc | LFL | Unclassified | |
| K013305 | Enoxaparin Test Card | Cardiovascular Diagnostics, Inc. | KFF | Class II | |
| K022707 | Liquichek Urine Toxicology Control Level S1e, Model 438; Level S2e, Model 439 | Bio-Rad | DIF | Class I | |
| K022480 | Acmi Disposable Bipolar Cord, Model Dbc | Acmi Corporation | HIH | Class II | |
| K022461 | S2 Femoral Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K022427 | Contour Se Microspheres | Boston Scientific Corporation | HCG | Class II | |
| K022402 | Disposable Pressure Manometer | Vital Signs, Inc. | CAP | Class II | |
| K022397 | Signa 3.0T Magnetic Resonance System | GE Healthcare | LNH | Class II | |
| K022128 | Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens | Bausch & Lomb Incorporated | HQD | Class II | |
| K022102 | Cleantexx Powderfree Barrier-Pro Synthetic Butadiene Copolymer Examination Gloves, Blue Colour | Latexx Manufacturing Sdn.Bhd. | LZA | Class I | |
| K021293 | Arteria Blood Filter | Arteria Medical Science, Inc. | FPB | Class II |