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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K812008 | Cordiotomy Reservoir | Bentley Laboratories, Inc. | DTN | Class II | |
| K812004 | Gastrin Ria Diagnostic Kit | Abbott Medical | CGC | Class I | |
| K811998 | Staph-Ident | Analytical Products, Inc. | JTO | Class I | |
| K811988 | Eagle I Hearing Aid | Electone, Inc. | ESD | Class I | |
| K811985 | Ultipor Sq40s Blood Transfusion Filter | Pall Biomedical Products Co. | CAK | Class II | |
| K811982 | Staphase* | Analytical Products, Inc. | JTL | Class I | |
| K811980 | Electronic Blood Pressure Transducer Man | H.R. Biomedical, Ltd. | DRS | Class II | |
| K811943 | Machida Nasopharyngo-Laryngoscope | Machida America, Inc. | EQN | Class II | |
| K811936 | Chemical Autoclave Indicator Tape | American Hospital Supply | JOJ | Class II | |
| K811928 | Lifesound Esophageal Stethoscope | Biomedical Concepts, Inc. | BZT | Class II | |
| K811926 | Se Won(aluminum) Dental Floss Holder | Sewon Industry | JES | Class I | |
| K811915 | Monitor/vital Signs Tray | American Hospital Supply | FME | Class I | |
| K811911 | Single Channel Non-Fade Oscilloscope | Quinton, Inc. | DXJ | Class II | |
| K811900 | Century Saf-Lift & Saf-Kary | Century Manufacturing Co. | FNG | Class II | |
| K811897 | Lic Turnover Bed | Century Manufacturing Co. | FNL | Class II | |
| K811820 | Bipolar Coagulating Forceps | New England Surgical Instrument Corp. | GEI | Class II | |
| K811802 | Hematoxylin | Richard-Allan Medical Ind., Inc. | HYJ | Class I | |
| K811801 | Cal-Rite | Richard-Allan Medical Ind., Inc. | KDX | Class I | |
| K811798 | Clear-Rite | Richard-Allan Medical Ind., Inc. | KEM | Class I | |
| K811797 | Eosin-Y | Richard-Allan Medical Ind., Inc. | HYB | Class I | |
| K811796 | Formal Alcohol | Richard-Allan Medical Ind., Inc. | PPM | Class I | |
| K811795 | 10% Neutral Buffered Formaldehyde | Richard-Allan Medical Ind., Inc. | IFP | Class I | |
| K811794 | 37% Formaldehyde | Richard-Allan Medical Ind., Inc. | IGG | Class I | |
| K811668 | Kulzer Translux Visible Light Curing | Kulzer GmbH | EBZ | Class II | |
| K811582 | The Placer | Cavitron Corp. | EID | Class I | |
| K811563 | Presolder for Non-Precious Dental Alloys | Williams Gold Refining Co., Inc. | EJS | Class II | |
| K811094 | Cardiac 1000 Tm | American Edwards Laboratories | JAA | Class II | |
| K810689 | Balloon Catheter | Surgimed Corp. | |||
| K812003 | A-Gent Theophylline | Abbott Medical | KLS | Class II | |
| K811994 | Radioimmunoassay Luteinizing Hormone | Endocrine-Metabolic Center | CEP | Class I | |
| K811990 | Trach Cleaning Tray | Associated Medical Products Co. | FRL | Class I | |
| K811987 | Oxy-Quik Mark IV Oxygen Inhalator | Oxequip Health Ind. | DRM | Class II | |
| K811975 | Model 480 Variable Wavelength Ultra Viol | Waters Assoc., Inc. | JJQ | Class I | |
| K811958 | Boundary Reinforced or Gown | The Buckeye Cellulose Corp. | FYA | Class II | |
| K811954 | Combo-Fer Iron Diagnostic | Immuno Assay Corp. | JQG | Class I | |
| K811941 | Neocept | Organon LLC | JHJ | Class II | |
| K811894 | Ortho Sickle Cell Controls | Ortho Diagnostic Systems, Inc. | GKA | Class II | |
| K811887 | Skin Staple Extractor | Sierra Laboratories, Inc. | KBC | Class I | |
| K811836 | Po-200 Blood Oxygen Monitor | Sumitomo Electric Industries, Inc. | KLK | Class II | |
| K811784 | Sigma Procedure #890 | Sigma Chemical Co. | GJS | Class II | |
| K811780 | Accra-Lab Gram Stain Set 55760 | Accra Laboratories, Inc. | JTS | Class I | |
| K811719 | Custom in-the-Ear Hearing Aid | Hearing Health Group, Inc. | ESD | Class I | |
| K811402 | Command P5(bipolar Pulse Generator) | Cardiac Pacemakers, Inc. | DXY | Class III | |
| K811401 | Command P5(unipolar Pulse Generator) | Cardiac Pacemakers, Inc. | |||
| K811290 | Arachidonic Acid | Bio/Data Corp. | JBX | Class II | |
| K811189 | Chemstrip L | Biodynamics Corp. | GHD | Class I | |
| K811105 | Semi-Constraint Kee Joint Hinge Prosth | Allo Pro Corp. | KRO | Class II | |
| K811923 | R & S Series Implants | Suncoast Dental, Inc. | DZE | Class II | |
| K811889 | R & S Series Fitting Tools | Suncoast Dental, Inc. | EIC | Class I | |
| K811502 | Stimulator, Facial-Models Sf-100 & 200 | Rcx-Western, Inc. | IPF | Class II |