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 |
|---|---|---|---|---|---|
| K951362 | Thyroglobulin Eia Test Kit | Immunoprobe, Inc. | JNL | Class II | |
| K951124 | Cad-2000 Cardiac Assist Device | Eee Medical Ent. | DRM | Class II | |
| K946258 | Model 8000 Atlas C-1 Orthogonal Adjusting Instrument | Spinalight Inc | LXM | Unclassified | |
| K945961 | Calcitonin Immunoassay Kit | Nichols Institute Diagnostics | JKR | Class II | |
| K945548 | Medivax | Vitajet Corp. | KZE | Class II | |
| K945400 | Hitachi Dynamic 3D Imaging System,sf-Va100 | Hitachi Medical Corp. of America | IZI | Class II | |
| K945138 | Omega 5600 Series Non-Invasive Blood Pressure Monitors | Invivo Research, Inc. | DXN | Class II | |
| K944600 | Graham-Field Saline Electrolyte Gel | Chester Labs, Inc. | GYB | Class II | |
| K940645 | Key-Lok(tm) System | St. Paul Medical | FMI | Class II | |
| K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | IWB | Class II | |
| K954504 | K-Defib/pace Pediatric Electrode | Katecho LLC | MKJ | Class III | |
| K954391 | Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter | Bio-Tek Instruments, Inc. | DRL | Class II | |
| K954328 | Clean Room Wheelchair | Forth Research, Inc. | IOR | Class I | |
| K954227 | Cedia Dau Methadone Assay | Microgenics Corporation | DJR | Class II | |
| K954037 | Field Trend | Synemed, Inc. | HPT | Class I | |
| K953973 | Angiovision 1000 | Medivision Medical Imaging, Ltd. | HKI | Class II | |
| K953972 | Angiovision Viewing Station | Medivision Medical Imaging, Ltd. | HKI | Class II | |
| K953959 | Phaco Handpiece for Phaco Fragmentation Machines, Phaco Sleeve for Attachment to Phaco Handpieces | MicroSurgical Technology Inc | HQC | Class II | |
| K953458 | Rainbow Step Up Systems Inc. Asthma Home Care Plan | Raiinbow Step UP Systems, Inc. | BZH | Class II | |
| K952224 | Stryker Constavac Blood Conservation System II (Cbcii) | Stryker Corp. | CAC | Class II | |
| K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55 (Ocufilcon D) Ghydrophilic Contact Lens | Permeable Technologies, Inc. | LPL | Class II | |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System | 3M Health Care, Sarns | DWA | Class II | |
| K950247 | Ts 564/Pf | Bressler, Amery & Ross | FJK | Class II | |
| K950223 | Discovery Graphic Portable Spirometer | Futuremed America, Inc. | BZG | Class II | |
| K943305 | Olympus 3D Surgical Endoscopy System | OLYMPUS Corporation of the Americas | HET | Class II | |
| K935998 | Enterprise | Camp Intl., Inc. | DQX | Class II | |
| K954882 | Riza-Ribe Needle (Modification) | R-Med, Inc. | HRX | Class II | |
| K953980 | Kreuzer Ceiling Mounted Support Systems, Klinoport | Kreuzer Corp. | FQO | Class I | |
| K953929 | Mid-Stream Collection Set-Sterile | Trinity Laboratories, Inc. | LIO | Class I | |
| K952277 | Sharplan Model 2040 Pulsed Cth:yag Surgical Laser System | Sharplan Lasers, Inc. | GEX | Class II | |
| K952254 | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | Pyramid Biological Corp. | GQI | Class II | |
| K951800 | Cmv Igg Human Serum Controls | Pyramid Biological Corp. | GQI | Class II | |
| K951770 | Biodex System 3 Model S3s-Ap and Model S3d-3Ap | Sport Medical Technology Inc | IKK | Class II | |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles | Global Medical Products, Ltd. | FCG | Class II | |
| K940316 | Hysterscope | Stephen Chakoff, Inc. | HIH | Class II | |
| K935716 | Karl Storz Fixed Magnification Telescope/ks Variable Magnification Telescope | Karl Storz Endoscopy-America, Inc. | HIH | Class II | |
| K932691 | Protectrode Systems Concentric | The Electrode Store | IKT | Class II | |
| K932436 | Echomark Intrauterine Guiding Catheter | Echocath, Inc. | MOV | Class II | |
| K954880 | Latex Patient Examination Glove (Powderfree/hypoallergenic) (Modification) | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K954876 | American Dental Products Root Canal Sealer, Wach's Formula | American Dental Products, Inc. | EMA | Class II | |
| K954837 | Dw260 19 | Ivoclar North America, Inc. | EJT | Class II | |
| K954795 | At2 & Doyle Style (C-Flex) Vent Tubes | Trebay Medical Corp. | ETD | Class II | |
| K954662 | Thermalastic/tripolyvinalene | Tak Systems | ELW | Class II | |
| K954491 | Hydrocell Nasal and Sinus Packs | Smith & Nephew Richards, Inc. | EMX | Class I | |
| K954433 | Vasport Dual Lumen Vascular Access System | Gish Biomedical, Inc. | LJT | Class II | |
| K954348 | Glanz Carcinoma Gauge, Ksea | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K954077 | Unitrax V40 Modular Adaptor | Howmedica Corp. | KWL | Class II | |
| K954051 | Sime Powderfree Plus | Sime Health, Ltd. | LYY | Class I | |
| K954025 | Sime Surgical Powderfree | Sime Health, Ltd. | KGO | Class I | |
| K953912 | Jacobyscope | Perioview, LLC | EIA | Class I |