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 |
|---|---|---|---|---|---|
| K071689 | Devilbiss Intellipap Model Dv 5 Series | Sunrise Medical, Inc. | BZD | Class II | |
| K071688 | Reliance S.e.p. | Reliance Orthodontic Products, Inc. | KLE | Class II | |
| K071391 | Philips Heartstart 12 Lead Transfer Station, Model 989803142521 | Philips North America LLC | MSX | Class II | |
| K071348 | Ems-Xl Cardiac Electrophysiology System | Mennen Medical, Inc. | DQK | Class II | |
| K071255 | Zymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040a | Hyphen Biomed Sasu | LCO | Class II | |
| K071145 | Nipro Safetouch Tulip Safety Fistula Needle | Nipro Medical Corporation | MPB | Class II | |
| K071118 | Gold Cup Electrode, Silver Cup Electrode and Electrode with Ag-Ag/cl Coating and Conductive Plastic Electrode | Ives EEG Solutions | GXY | Class II | |
| K062028 | Cystic Fibrosis Genotyping Assay, Model 6L20-01 | Celera Diagnostics | NUA | Class II | |
| K060676 | Nes Reprocessed Endoscopic Trocar | Northeast Scientific Inc. | NLM | Class II | |
| K072281 | Nexgen Prolong All-Poly Patella | Zimmer GmbH | JWH | Class II | |
| K072167 | Comfortpress Vascular Compression Assist Device | Advanced Vascular Dynamics | DXC | Class II | |
| K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | GEI | Class II | |
| K071910 | Nitrile Powder Free Examination Gloves (Blue), Nitrile Powder Free Examination Gloves (Pink) | Hartalega Sdn Bhd | LZA | Class I | |
| K071577 | Biomet Microfixation Lactosorb Pectus Stabilizer | Biomet Microfixation | HRS | Class II | |
| K071221 | Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12 | Automedx, Inc. | BTL | Class II | |
| K071196 | Disposable High Pressure Injection Lines with and without Rotating Adapters | Coeur, Inc. | DQO | Class II | |
| K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | NKB | Class II | |
| K072183 | St360 Spinal Fixation System, Model 07.0029-7500.5600 | Zimmer Spine, Inc. | NKB | Class II | |
| K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | GEI | Class II | |
| K072164 | Dc-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | ITX | Class II | |
| K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer GmbH | MBH | Class II | |
| K071966 | 1.5T Mrgfus Pelvic Coil | Insightec Txsonics, Inc. | MOS | Class II | |
| K071951 | Comfy Series: Ev-804, Ev-805 & Ev-806 | Everyway Medical Instruments Co., Ltd. | GZJ | Class II | |
| K071661 | Alphaone Biofeedback System | Telediagnostic Systems, Inc. | HCC | Class II | |
| K070895 | Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10 Challenge Pack | STERIS Corporation | JOJ | Class II | |
| K072085 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | LYZ | Class I | |
| K071824 | Acme Talon Pedicle Screw | Acme Spine, LLC | MNI | Class II | |
| K071817 | Osteograf/n-300 | Dentsply Interntional | LYC | Class II | |
| K071418 | Dana 3Cc Syringe Insulin Reservoir | Sooil Development Co., Ltd. | MRZ | Class II | |
| K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | Depuy Orthopaedics Inc. | FTM | Class II | |
| K070531 | Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer | Thermo Fisher Scientific Oy | CGZ | Class II | |
| K072172 | Jostra Pediatric Arterial Prefusion Cannulae | MAQUET CARDIOPULMONARY GmbH | DWF | Class II | |
| K072127 | Dominator | Biocomposites, Ltd. | HWC | Class II | |
| K072108 | Modification to Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.r.l. | FLL | Class II | |
| K072006 | Dar-9400F | Shimadzu Corp. | IZI | Class II | |
| K071863 | Activapin, Nexfix Rfs Pin, Nexfix Resorbable Fixation System (Rfs) | Bioretec Ltd. | HTY | Class II | |
| K071858 | Dental Matrix Band | Fly Cast Technologies, Inc. | DZN | Class I | |
| K071660 | Visions Pv 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900 | Volcano Corporation | OBJ | Class II | |
| K071606 | Biosign Central Station | OBS Medical Ltd | MWI | Class II | |
| K071584 | Oasis Release 1.0 | Segami Corporation | LLZ | Class II | |
| K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips North America LLC | DRG | Class II | |
| K071470 | Implantech Eptfe Sheeting, Model Eptfe-Xxx | Implantech Associates Inc | FTL | Class II | |
| K071328 | Visualase Thermal Therapy System | Biotex, Inc. | GEX | Class II | |
| K071299 | Ip System, Oculab Ip, Optomize Ip, Retasure Ip | Digital Healthcare, Ltd. | NFJ | Class II | |
| K071225 | Innovasa Stat*seal Topical Hemostat | Innovasa, Inc. | DXC | Class II | |
| K071168 | The Portable Ansiscope | Dyansys, Inc. | DPS | Class II | |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model Cf-5560 | Medigroup | FJS | Class II | |
| K071080 | Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M | E Surgical, LLC | GEI | Class II | |
| K070795 | Sphygmocor Cardiovascular Management System | ATCOR MEDICAL Pty Ltd | DSK | Class II | |
| K070754 | Trabecular Metal Vertebral Body Replacement (Vbr), Model# 06-115, 06-155 | Zimmer Trabecular Metal Technology, Inc. | MQP | Class II |