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 |
|---|---|---|---|---|---|
| K072097 | Bilibee LED Phototherapy System, Model: 1 | Medical Select, Inc. | LBI | Class II | |
| K070315 | Lina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8 | LiNA Medical Inc | KNF | Class II | |
| K072918 | Model Ssa-680A Xario Xg Diagnostic Ultrasound System, Version 1.00 | Toshibamedical Systems Corporation | ITX | Class II | |
| K072343 | Neurovision Jjb System | NuVasive Inc | GWF | Class II | |
| K072298 | Biopro Memory Staple, Models 18062-18073 | Biopro, Inc. | JDR | Class II | |
| K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/venous Reservoir | Corcym Inc. | DTZ | Class II | |
| K071990 | Valeo Cervical Plate System | Amedica Corp. | KWQ | Class II | |
| K071912 | Apaceram Bone Graft Substitute | Pentax Corp. | MQV | Class II | |
| K071445 | Terraquant Mq2000 V.5 with the Tq-1Tens | Escada International, Inc. | ILY | Class II | |
| K062542 | Z-Look3 Dental Implant System, Model Z3-Xxx | Z-Systems AG | DZE | Class II | |
| K072900 | Excelarrest Foam | Hemostasis, LLC | QSY | Unclassified | |
| K072727 | Inratio 2 Pt Monitoring System | Hemosense, Inc. | GJS | Class II | |
| K072612 | Access Immunoassay Systems Br Monitor, and Calibrators, Model(s) 387620,And 387647 | Siemens Healthcare Diagnostics Inc. | MOI | Class II | |
| K072545 | Artiste Se Flowable Composite, Model N280 | Pentron Clinical Technologies | EBF | Class II | |
| K072529 | Trackport | Direx Systems Corp. | IYE | Class II | |
| K072506 | Exactrac 5.5 | Brainlab, Inc. | IYE | Class II | |
| K072262 | Gentleray 980 Diode Laser System | Kavo America | GEX | Class II | |
| K072200 | Stimlab | Micropace Pty. Ltd. | JOQ | Class II | |
| K072086 | Infinitas Mini-Implant System/guidance System | D B Orthodontics Ltd | OAT | Class II | |
| K072063 | Kfx Tissue Fixation System and Accessories | Kfx Medical | MBI | Class II | |
| K072026 | Rnk Electronic Stethoscope | Rnk Products, Inc. | DQD | Class II | |
| K071981 | Bonart Model Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips) | Bonart Co. Ltd. | ELC | Class II | |
| K071787 | Bemitt, Model 0001 | Dja Distributors, LLC | IZH | Class II | |
| K071493 | Clever Chek Td-4209 Blood Glucose Monitoring System, Model Td-4209, Td-4222, Td-4225 | Taidoc Technology Corporation | NBW | Class II | |
| K071313 | Trojan-Enz Brand | Church & Dwight Co., Inc. | HIS | Class II | |
| K072898 | Hexapod Evo Rt Couch Top | 3C-Medical Intelligence GmbH | JAI | Class II | |
| K072800 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K072680 | Drystar Axys, Model Eyz4e | AGFA Healthcare Corp. | LMC | Class II | |
| K072472 | Disposable Vinyl Examination Glove, Powdered | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K072294 | System-Mini, Models: 390, E30 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K072191 | Clearvision Nuclear Medicine Imaging System | Gvi Technology Partners | KPS | Class II | |
| K072083 | Small Fragment Locking Plating System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K071904 | Deployable Oxygen Generation System - Medium (Dogs-M) | Mission Systems Davenport Inc. | CAW | Class II | |
| K071737 | General Semen Analysis Kit | Dyn-Bioshaf (2006), Ltd. | POV | Class II | |
| K071652 | Hemocue Wbc System | HemoCue AB | GKL | Class II | |
| K072826 | Aplio Artida Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | ITX | Class II | |
| K072706 | Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed Drill | Conmed Linvatec | HRX | Class II | |
| K072422 | Cyberwand Sterile Pads, Model: Cw-Rbpbx | Cybersonics, Inc. | FFK | Class II | |
| K072327 | Cancello-Pure Bone Wedge, 12Mm Evans or 6Mm Cotton | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K072081 | Zodiac Dynamo Semi-Rigid Spinal System | Alphatec Spine, Inc. | KWP | Class II | |
| K071764 | Realize Gastric Calibration Tube, Models Gct180, Gct360 | Obtech Medical SARL | KNT | Class II | |
| K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | DRE | Class II | |
| K070265 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model 01-090000 | Ortho-Clinical Diagnostics, Inc. | GQN | Class II | |
| K072865 | Modificaton to: Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K072824 | Fox Sv Pta Catheter | Abbott Medical | LIT | Class II | |
| K072768 | Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants | Lifecore Biomedical LLC | DZE | Class II | |
| K072705 | Asahi Ptca Guide Wire, Fielder Fc J, Models: Agp140001j, Agp140301j | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800Sr | Genesee BioMedical, Inc. | KRH | Class II | |
| K072636 | A-Bsm Bone Substitute Material | Etex Corp. | MQV | Class II | |
| K072519 | Activator V Spinal Adjusting Instrument | Activator Methods International Ltd. | LXM | Unclassified |