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 |
|---|---|---|---|---|---|
| K182511 | SimplCath | F&S Medical Solutions, LLC | GBM | Class II | |
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu) Ltd | JOW | Class II | |
| K190379 | MIM on Linux | MIM Software Inc | LLZ | Class II | |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corp. | OMC | Class II | |
| K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | LLZ | Class II | |
| K182793 | AP3600 Automated Instrument | Canon Medical Diagnostics USA, Inc. | DHB | Class II | |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | |
| K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | Yty Industry (Manjung) Sdn. Bhd. | LZC | Class I | |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | CBK | Class II | |
| K190366 | BRAUN Silk Expert Pro 3 | Cyden Limited | OHT | Class II | |
| K190361 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | |
| K190354 | BRAUN Silk.expert Pro 5 | Cyden Limited | OHT | Class II | |
| K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | ConMed Corporation | MBI | Class II | |
| K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | OZE | Class II | |
| K183518 | Preat Abutments | Preat Corporation | NHA | Class II | |
| K183511 | Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) | Medtronic, Inc. | DTZ | Class II | |
| K183344 | The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC | JWH | Class II | |
| K183296 | REAL Immersive System | Penumbra Inc. | ISD | Class II | |
| K183260 | Sensilight Pro / Pistol IPL | El Global Trade Ltd. | OHT | Class II | |
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Siemens Healthcare Diagnostics Inc. | QFS | Class II | |
| K190359 | Sonendo GentleWave System | Sonendo Inc | ELC | Class II | |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K190401 | MAMBA and MAMBA Flex Microcatheters | Boston Scientific Corporation | DQY | Class II | |
| K190373 | SonialVision G4 | Shimadzu Corp. | JAA | Class II | |
| K190357 | Star-X, Intraoral X-ray System | HDX Will | EHD | Class II | |
| K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek Inc. | NUH | Class II | |
| K190294 | CELL-DYN Emerald 22 AL System | Abbott Medical | GKZ | Class II | |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | Corinth Medtech, Inc. | FJL | Class II | |
| K183657 | Vantage Galan 3T, MRT-3020/A9, V5.0 | Canon Medical Systems Corporation | LNH | Class II | |
| K183501 | Parcus Twist AP Suture Anchors | Parcus Medical, L.L.C. | MAI | Class II | |
| K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | DQY | Class II | |
| K183426 | MectaLIF Anterior Stand Alone Extension | Medacta International SA | OVD | Class II | |
| K183187 | nextaro Transfer System, nextaro va | SFM Medical Devices GmbH | LHI | Class II | |
| K182853 | HORIZON TMS Therapy System | Magstim Inc. | OBP | Class II | |
| K182813 | Cohitech Organic Cotton Applicator Tampons Light | Cotton High Tech S.L. | HEB | Class II | |
| K182639 | MOBILETT Elara Max | Siemens Medi Cal Solutions, Inc. | IZL | Class II | |
| K182571 | CardioFlux with Faraday Analytical Cloud | Genetesis, Inc. | DPS | Class II | |
| K182022 | ApexMV | Incontrol Medical, LLC | KPI | Class II | |
| K181633 | MTF Pre-Sutured Tendon | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | GAT | Class II | |
| K180127 | TCAT (R) THA Instrument Tray Set | Think Surgical Inc. | KCT | Class II | |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | CDN | Class II | |
| K190318 | VASOBand Vascular Compression Device | Vasoinnovations Inc. | DXC | Class II | |
| K190285 | L300 Go System | Bioness, Inc. | GZI | Class II | |
| K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | MQV | Class II | |
| K190168 | Aquas Probes | Genicon, Inc. | GEI | Class II | |
| K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | LYR | Class I | |
| K183380 | Tetric PowerFill | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K183247 | dpl Faceware | LED Technologies, Inc. | OHS | Class II |