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 |
|---|---|---|---|---|---|
| K081067 | Fracture/reconstruction System (Traumaone) | Biomet Microfixation | JEY | Class II | |
| K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs) | Varian Medical Systems, Inc. | IYE | Class II | |
| K081014 | Soyala Gel Vented | Weinmann Gerate Fur Medizin GmbH + Co. KG | BZD | Class II | |
| K080999 | Pagewriter Cardiograph | Philips North America LLC | DPS | Class II | |
| K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | IYE | Class II | |
| K080674 | Pajunk's Primocut Disposable Biopsy System | Pajunk GmbH Medizintechnologie | MJG | Class I | |
| K080655 | Chrysalis | Meta Imaging Solutions, LLC | KPR | Class II | |
| K080612 | Leica Fl800 | Leica Microsystems (Schweiz) AG | IZI | Class II | |
| K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | MEH | Class II | |
| K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | MAX | Class II | |
| K080359 | Evolution Esophageal Stent System | Cook Ireland Ltd. | ESW | Class II | |
| K080256 | Pulmodyne Chf Flow Generator System | Engineered Medical Systems, LLC | BYE | Class II | |
| K080187 | Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps | Olsen Medical | GEI | Class II | |
| K080177 | Wrist Blood Pressure Monitor, Model Ws-1100/Ws-1100Pv | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K080140 | Laurimed Spinal Injection System | Laurimed, LLC | BSP | Class II | |
| K073477 | Photonova Family of Pulsed Light Systems | Photonova Ofsweden AB | GEX | Class II | |
| K072616 | Axxent Vaginal Applicator | Xoft, Inc. | JAD | Class II | |
| K072595 | Omni-Tight | Basic Dental Implant Systems, Inc. | DZE | Class II | |
| K072410 | Ksea Clearvision II, Model 40334120 | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K063583 | Alcon Vision System | Alcon, Inc. | HQC | Class II | |
| K081162 | Temptouch Dermal Thermometer | Diabetica Solutions, Inc. | FLL | Class II | |
| K081136 | Lyric Hearing Aid | Insound Medical, Inc. | ESD | Class I | |
| K080654 | Pajunk's Kit for Balloon Aided Laparoscopy | Pajunk GmbH Medizintechnologie | GCJ | Class II | |
| K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | LPH | Class II | |
| K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model Cdf | Micrus Endovascular Corporation | HCG | Class II | |
| K080313 | Modification to Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K080202 | Oncobionic System with 6 Probe Output | Oncobionics, Inc. | OAB | Class II | |
| K080012 | Platelia Lyme Igg Assay | Bio-Rad | LSR | Class II | |
| K073675 | T-Pump Localized Temperature Therapy Pump | Gaymar Industries, Inc. | ILO | Class II | |
| K073370 | Tc Matrix Clinical Chemistry Analyzer | Teco Diagnostics | JJE | Class I | |
| K073207 | Olympus Esg-100, Model Wb991046; Olympus Afu-100, Model Wb950167 | Celon AG Medical Instruments | GEI | Class II | |
| K072456 | Desara Mesh Sling, Model Cal-Ds01 | Caldera Medical, Inc. | OTN | Class II | |
| K072251 | Merete Toemobile Anatomical Great Toe Resurfacing System | Merete GmbH | LZJ | Unclassified | |
| K072084 | Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | LYZ | Class I | |
| K071999 | Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | |
| K081082 | U-Clip Uni-Fire, Model M65 | Medtronic, Inc. | FZP | Class II | |
| K080988 | Scoutpro Cs Lead Introducer System | BIOTRONIK AG | DQY | Class II | |
| K080824 | Bio-Console 560 | Medtronic Perfusion Systems | DWA | Class II | |
| K080648 | Traumastat Rapid Hemostatic Wound Dressing Bandage | Ore-Medix, LLC | QSY | Unclassified | |
| K080569 | Ldr Spine Roi-T Implant | Ldr Spine USA | MQP | Class II | |
| K073592 | Optistar Elite Injection System | Mallinckrodt Inc., Liebel-Flarsheim Business | DXT | Class II | |
| K072536 | Esa Biosciences Inc. Vitamin D Hplc Test | Magellan Diagnostics, Inc. | MRG | Class II | |
| K072236 | Durex Play Tingling Aqueous Based Lubricant | Ssl Americas, Inc. | NUC | Class II | |
| K070463 | Revera Wound Care, Model Mdw0060 | Revalesio Corporation | FRO | Unclassified | |
| K070104 | Prolyte Electrolyte Analyzer | DIAMOND DIAGNOSTICS Inc | JGS | Class II | |
| K081007 | Zimmer M/l Taper Hip Prosthesis with Kinectiv Technology System | Zimmer GmbH | KWA | Class III | |
| K080980 | Exactech Novation Element Press-Fit Femoral Stems | Exactech, Inc. | MEH | Class II | |
| K080764 | Success Cecal Intubation Assist, Model: 4100 | Max Endoscopy, Inc. | ODC | Class II | |
| K080712 | Serim Hisense Ultra 0.1, Part Number 5167 | Serim Research Corp. | MSY | Class II | |
| K080590 | Aos Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | KTW | Class II |