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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K901107 | Modified Auto Suture Purstring Disp. Automatic | United States Surgical, A Division of Tyco Healthc | GDJ | Class I | |
| K901059 | Automated Eia Microplate Reader Models El340/340i | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K901027 | Automated Eia Microplate Reader Models El312/312i | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K900828 | Perkin-Elmer Aa 3100 Atomic Absorption Spectro. | Revvity Health Sciences, Inc. | JXR | Class I | |
| K900533 | Disposable Bipolar Coagulating Forceps | Kirwan Surgical Products, LLC | GEI | Class II | |
| K900209 | Willi Geller Ceramic Creation & Surprise | Creation North America, Inc. | EIH | Class II | |
| K896608 | Spag Pak | Viratek, Inc. | BYL | Class I | |
| K896323 | Wilson-Cook Endoscopic Nasal Biliary Drainage Sets | Wilson-Cook Medical Inc. | FGE | Class II | |
| K896318 | Wilson-Cook Cytology Brushes | Wilson-Cook Medical Inc. | FDX | Class II | |
| K895945 | Ktp/532 Surgical Laser System W/ktp/yag Module | Laserscope | GEX | Class II | |
| K895854 | Acme Preformed Coated Ligature Ties (Tooth Shade) | Acme-Monaco Corp. | EJF | Class I | |
| K895734 | Deseret Intravascular Catheter | Deseret Medical, Inc. | FOZ | Class II | |
| K893636 | Guardian Forcep | Endo-Scientific, Inc. | FCL | Class I | |
| K900093 | Disposa-Shield(tm) Infection Control Barrier | Dentsply Intl. | EFB | Class I | |
| K895542 | Sonicath(tm) 5 F | Boston Scientific Corporation | DQO | Class II | |
| K901092 | Model 8010; Extremity Surface Coil | Medical Advances, Inc. | LNH | Class II | |
| K901054 | Bion Borrelia Burgdorferi Antigen Substrate Slide | Bion Ent., Ltd. | LSR | Class II | |
| K900937 | O.r. Data Manager | Draeger, Inc. | BSZ | Class II | |
| K900790 | Protex Latex Examination Glove | Seyen Intl., Inc. | LYY | Class I | |
| K900253 | Model 20-Ch Carbon Dioxide Laser W/add'l Uses | Pfizer Laser Systems | GEX | Class II | |
| K896858 | Solcotrans Intraoperative Autotransfusion System | Solco Basle, Inc. | CAC | Class II | |
| K896857 | Solcotrans Orthopaedic Drainage/reinfusion System | Solco Basle, Inc. | CAC | Class II | |
| K895956 | Rx02 Emergency Medical Oxygen | Progressive Medical Applications Corp. | CAN | Class I | |
| K894893 | Point Checker Color Strip Thermometer | Kyowa Medex Co., Ltd. | FQZ | Class I | |
| K894001 | Saliva Alcohol Test | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | DIC | Class II | |
| K890989 | Dr. Herzberg Disposable External Fixator | Origin Medsystems, Inc. | KTT | Class II | |
| K901152 | Redyplate Disposable Leg Plate | Medical Accessories, Inc. | HGP | Class II | |
| K901032 | Pci Model 2041-Pc Telemetry Monitor W/arrhythmia | Accucore, Inc. | DPS | Class II | |
| K901019 | Diacam Gamma Camera System | Siemens Gammasonics, Inc. | KPS | Class II | |
| K900913 | Adler Disposable Bipolar Cord | Adler Instrument Company | HQO | Class II | |
| K900871 | Alternating Pressure Pump and Pad System | Three Bears Intl. | FNM | Class II | |
| K900866 | Oximax 700 | Pace Tech, Inc. | DQA | Class II | |
| K900861 | Dahlberg Model Jh in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K900849 | Cardisuny, 501Bx | Graham-Field, Inc. | LOS | ||
| K900789 | Hearing Aid (All-in-the-Ear) | Solar Aid Corp. | ESD | Class I | |
| K900631 | Saliva Absorber - Dental | Kab Gloves Unltd. | DYN | Class I | |
| K900346 | Sharplan Nd:yag Laser Laparoscopic Cholecystectomy | Sharplan Lasers, Inc. | GEX | Class II | |
| K900123 | Auto Suture Surgiport Spiral Sleeve | United States Surgical, A Division of Tyco Healthc | FBQ | Class II | |
| K900091 | Modified Ophthalmic Opir Onufryk Image Deflector | Onufryk Low Vision Ent. | HQG | Class I | |
| K897155 | Mitek Anchor(tm) | Mitek Surgical Products, Inc. | JDR | Class II | |
| K897093 | Intraocular Microscissors by Means of Gamma Radia. | Microline Pentax, Inc. | HNF | Class I | |
| K896898 | Bowen Electrode Skin Prepatory Cleanser | Bowen & Company, Inc. | LKB | Unclassified | |
| K896622 | Visitec Vitrectomy Unit | Visitec Co. | HKP | Class II | |
| K895889 | Shake N' Spray (W/silhouette Porcelain) | Leach and Dillon Co., Inc. | EIH | Class II | |
| K895820 | Resuso Mask | Rml Ent., Inc. | BTM | Class II | |
| K895806 | Elatec Holter Analyzer | Ela Medical, Inc. | DSI | Class II | |
| K895801 | Mac-Lab Cardiac Catheterization Laboratory System | Marquette Electronics, Inc. | DRT | Class II | |
| K895462 | Osseodent Dental Attachments | Collagen Corp. | DZE | Class II | |
| K894087 | Surgeon's Gloves | Shangrila Latex Industries Pvt., Ltd. | KGO | Class I | |
| K893802 | Proview Self-Sealing Sterilization Pouch | Cottrell, Ltd. | KCT | Class II |