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 |
|---|---|---|---|---|---|
| K020998 | Sarns Centrifugal Pump with Xcoating, Model 164275X | Terumo Cardiovascular Systems Corporation | KFM | Class II | |
| K020997 | Apex Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator | Dideco S.p.A. | DTZ | Class II | |
| K020988 | Pain Care 4200 | Breg, Inc. | MEB | Class II | |
| K020970 | Modification to Oncology Salvage System (Oss) | Zimmer GmbH | JDI | Class II | |
| K020949 | Apollo, Model 1124525 | Sterngold | EJT | Class II | |
| K020946 | Adper Prompt | 3M Espe AG Dental Products | KLE | Class II | |
| K020933 | Garaventa Super-Trac Tre-52 | Garaventa Accessibility | ING | Class II | |
| K020789 | Ge Vivid 3 Expert; Ge Vivid 3 Pro | General Electric Co. | IYN | Class II | |
| K020773 | Long Length Gamma Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K020469 | Cal-Chex Cd Plus | Streck Laboratories, Inc. | KRX | Class II | |
| K020323 | Bd Phoenix Automated Microbiology System | Becton Dickinson & Co | LON | Class II | |
| K020258 | Support Sleeve | Pos-T-Vac, LLC | LKY | Class II | |
| K020154 | Vt-1 | Pos-T-Vac, LLC | LKY | Class II | |
| K020067 | Gyrus ENT Somnoplasty Generator | Gyrus Ent LLC | GEI | Class II | |
| K020058 | Medical Le | Barco N.V. | LLZ | Class II | |
| K013988 | Millex Gp Sterilizing Filter Unit, Model Slgp 033 R | EMD Millipore Corporation | BSN | Class II | |
| K013569 | Orthopilot 2 | Aesculap Inc | HAW | Class II | |
| K013428 | Mayfield/acciss Operating Arm System and Mayfield/optical Acciss System | Ohio Medical Instrument Co., Inc. | HAW | Class II | |
| K013369 | Resection Ablator | Linvatec Corporation | GEI | Class II | |
| K013210 | Truwave | Dan Med, Inc. | GZJ | Class II | |
| K013108 | Biosuc | Hakko Medical Co., Ltd. | KNW | Class II | |
| K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress | Echotech 3D Imaging Systems GmbH | IYO | Class II | |
| K020935 | Hemocue Glucose 201 System, Article Number 120706 | HemoCue AB | CGA | Class II | |
| K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Healthcare | JAK | Class II | |
| K020913 | CT-C3000 Spiral CT Scanner System | Neusoft Digital Medical Systems Co., Ltd. | JAK | Class II | |
| K020769 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International Inc | DLJ | Class II | |
| K020767 | Advanta Sst Bifurcated Graft | Atrium Medical Corporation | DSY | Class II | |
| K020761 | Power Tek II | Zimmer GmbH | HRX | Class II | |
| K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | HRX | Class II | |
| K020681 | Ebi Omega21 Spinal Fixation System | Ebi, LLC | MNH | Class II | |
| K020674 | Blackstone Spinal Fixation System 4.5Mm Multi-Axial Screw | Blackstone Medical, Inc. | MNH | Class II | |
| K020592 | Albahealth C.a.l.m. Sleeve, Model 59001 | Alba-Waldensian, Inc. | DWL | Class II | |
| K020455 | Tissuemend Soft Tissue Repair Matrix | Integra LifeSciences Braintree Inc. | FTM | Class II | |
| K020371 | Uplink Test System | OraSure Technologies, Inc. | DJG | Class II | |
| K020308 | Regent Biogel Skinsense Sterile Powder-Free, Synthetic Polyisoprene Surgeon's Glove | Ssl Americas, Inc. | KGO | Class I | |
| K020147 | Magellan Ratio Dispenser Kit/magellan Spray Tip/magellan Cannula Tip | Medtronic Perfusion Systems | FMF | Class II | |
| K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific Corporation | OTN | Class II | |
| K020061 | Imagedesk | Barco N.V. | LLZ | Class II | |
| K020059 | Mfcd 118I | Barco N.V. | LLZ | Class II | |
| K020024 | Caris Minitome Biopsy Instrument | Artemis Medical, Inc. | KNW | Class II | |
| K013762 | Rigid Gas Permeable Contact Lens | Bausch & Lomb Incorporated | HQD | Class II | |
| K013204 | Aquify Lens Comfort Drops | Alcon Laboratories | MRC | Class II | |
| K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp | LZO | Class II | |
| K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | JKA | Class II | |
| K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | DQX | Class II | |
| K020682 | Bard Luminexx 6 Fr Biliary Stent and Delivery System | C.R. Bard Inc | FGE | Class II | |
| K020221 | Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set | Biomet Orthopedics, Inc. | HRS | Class II | |
| K020043 | 4.0 Mm Arthrex Bio-Tendoesis Screw, Model Ar-1540B; 5.5 Mm Arthrex Bio-Tenodesis Screw, Models Ar-1555B | Arthrex GmbH | HWC | Class II | |
| K013363 | Crosspoint Transaccess Catheter | Trans Vascular Incorporated | ITX | Class II | |
| K013169 | Immune Cell Function Assay | Cylex, Inc. | NID | Class II |