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 |
|---|---|---|---|---|---|
| K012387 | Stg Multichannel Lung Sound Analysis System | Stethographics, Inc. | BZM | Class II | |
| K021048 | Thermometer Models St8631 | Z7 International | FLL | Class II | |
| K020868 | Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White) | Seal Polymer Industries Bhd. | LZA | Class I | |
| K020819 | Distal Radius Plating System | Zimmer GmbH | HRS | Class II | |
| K020746 | Bird Tbird Vela Ventilator | Bird Products Corp. | CBK | Class II | |
| K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529 | Bio-Rad | DIE | Class I | |
| K020589 | 3M Comply 1228 Gas Plasma Indicator Tape | 3M Company | JOJ | Class II | |
| K020555 | Sonata Micro Hybrid Composite | Pentron Laboratory Technologies | EBF | Class II | |
| K020499 | Bond-3 Adhesive | Jeneric/Pentron, Inc. | KLE | Class II | |
| K020397 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Piperacillin (4-256 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020294 | Motion Tracking | Accuray Incorporated | IYE | Class II | |
| K020244 | Synthes Thoracolumbar Spine Locking Plate (Tslp) | Synthes GmbH | KWQ | Class II | |
| K020218 | Snap EEG Monitor | Nicolet Biomedical, Inc. | OLW | Class II | |
| K020184 | Hommed Central Station | Hommed, LLC | DXN | Class II | |
| K013905 | Modification Ez-1 System Repiratory Sensors | Pro-Tech Services, Inc. | MNR | Class II | |
| K013865 | Tip Deflrcting Endobronchial Blocker | Cook Inc. | CBI | Class II | |
| K021213 | Modification to Hemashield Platinum Woven/microvel Double Velour Vascular Grafts | Boston Scientific Corporation | MAL | Class II | |
| K021136 | Teknique-Hoveround Power Wheel Chair | Hoveround Corp. | ITI | Class II | |
| K020919 | Atricure Bipolar System, Models Asu1, Asu2, Asu3, Lhp1, Lhp2, Rhp1 | AtriCure, Inc. | GEI | Class II | |
| K020918 | Elastyfree Synthetic Powder-Free Surgical Glove | Eci Medical Technologies, Inc. | KGO | Class I | |
| K020695 | Qab2a Igg Elisa Kit | Cheshire Diagnostics, Ltd. | MSV | Class II | |
| K020694 | Qab2a Igm Elisa Kit | Cheshire Diagnostics, Ltd. | MVS | Class II | |
| K020390 | Modification to Fetal Assist | Huntleigh Diagnostics, Ltd. | LQK | Class II | |
| K020303 | Xr Primer 2 | Kerr Dental Materials Center | KLE | Class II | |
| K020112 | 50S Tringa Ultrasound Imaging System | Pie Medical | IYO | Class II | |
| K020079 | Bladeworks Microkeratome Blade, Model 7061 | Blade Works, Inc. | HNO | Class I | |
| K014123 | Bactec Mgit 960 Sire Kits | Becton Dickinson & Co | MJA | Class II | |
| K013122 | Ems Electrostatic Fliter and Hme Combination | Engineered Medical Systems, LLC | CAH | Class II | |
| K020931 | Bact/alert Sa Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K020923 | Bact/alert Pf Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K020815 | Bact/alert Fn Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K013281 | Versalab Apm | Nicolet Biomedical, Inc. | HGM | Class II | |
| K021139 | Truline Reinforced Valved Infusion Catheter | Medtronic, Inc. | FOZ | Class II | |
| K021077 | Mega 2000 Soft Patient Return Electrode Pad | Megadyne Medical Products, Inc | GEI | Class II | |
| K021049 | Oec 9800 Plus Digital Mobile Imaging System | GE Healthcare | OWB | Class II | |
| K020955 | Nicolet Electrocautery Detector | Nicolet Biomedical, Inc. | ETN | Class II | |
| K020947 | Modification to Dyonics Intelijet Reusable Cannulas | Smith & Nephew, Inc. | FRN | Class II | |
| K020940 | Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00X | Sutura, Inc. | GAW | Class II | |
| K020890 | Spyglass 4 Fr Angiographicy Catheter | Abbott Medical | DQO | Class II | |
| K020864 | Edwards Mc Tricuspid Annuloplasty System, Model 4900 | Edwards Lifesciences LLC | KRH | Class II | |
| K020858 | Nxstage Therapy System | NxStage Medical Inc | KDI | Class II | |
| K020813 | Bact/alert Fa Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K020506 | Microscan Synergies Plus Gram-Negative Mic/combo Panels with Ceftriaxone (0.5-128 Ug/ml) | Dade Microscan, Inc. | LON | Class II | |
| K020481 | Pulpdent Post Cement | Pulpdent Corporation | EMA | Class II | |
| K020432 | Pulpdent Glaze | Pulpdent Corporation | EBF | Class II | |
| K020387 | Myallergytest System | Immunetech Corporation | DHB | Class II | |
| K020319 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Ampicillin/sulbactam (0.5/0.25-64/34 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020292 | Uterine Injector | Biomerics | LKF | Class II | |
| K020253 | 4 All (Dw286a) | Ivoclar Vivadent, Inc. | EJH | Class II | |
| K020242 | Emulate Fast Set and Emulate Regular Set | Cavex Holland B.V. | ELW | Class II |