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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143314 | Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | LPH | Class II | |
| K143303 | Single Use Biliary Balloon Dilator | Olympus Medical Systems Corp. | FGE | Class II | |
| K142731 | HEARTWAY Electrically Powered Wheelchairs | Heartway Medical Products Co., Ltd. | ITI | Class II | |
| K142172 | Lightmed Truscan 577 | Lightmed Corp. | HQF | Class II | |
| K142119 | Procotyl L-O Acetabular System | Microport Orthopedics Inc. | LPH | Class II | |
| K141922 | Iris Intelligent Retinal Imaging System | Intelligent Retinal Imaging Systems, Inc. | NFJ | Class II | |
| K141559 | V-Guide for Ventriculostomies | Arc Surgical, LLC | HAW | Class II | |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | Becton, Dickinson and Company, BD Biosciences | OYE | Class II | |
| K141183 | Evo 500 Series High Speed Handpieces/tiger 500/300/101 Series High Speed Handpieces | Ttbio Corp. | EFB | Class I | |
| K141123 | Alliance Spine Raas Cranial Plating System | Alliance Partners, LLC | GWO | Class II | |
| K140990 | Ems Piezon 707 Bik and Piezon 707 Bik LED | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | MXA | Class II | |
| K150190 | IntraTemp Solution Warmer | Microtek Medical LLC | LHC | Class I | |
| K150174 | Emma | Inrange Systems, Inc. | NZH | Class II | |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | WHPM Inc. | LAF | Class II | |
| K143652 | Vector PTA Balloon Dilatation Catheter | Vector Corporation, LLC | LIT | Class II | |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | LKF | Class II | |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K143323 | OS2-V Varisation Staple | In2Bones SAS | JDR | Class II | |
| K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | OVD | Class II | |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. | EMA | Class II | |
| K142576 | Spinal System | Eisertech, LLC | NKB | Class II | |
| K142498 | MAGNIFY and MAGNIFY-S Spacers | Globus Medical, Inc. | OVD | Class II | |
| K142178 | Proroot Mta White, Proroot Mta Gray | Dentsply International, Inc. | KIF | Class II | |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | PGM | Class II | |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | Guangzhou Wondfo Biotech Co., Ltd. | DJG | Class II | |
| K150020 | Irritrol, EDS Combo-Rinse | Essential Dental Systesm, Inc. | KJJ | Unclassified | |
| K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | HRS | Class II | |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K143417 | ANAX 5.5 Spinal System | CG MedTech Co., Ltd. | MNH | Class II | |
| K143350 | Nile Alternative Fixation | K2M, Inc | OWI | Class II | |
| K143230 | Palladian Lumbar Pedicle Screw System | Neurostructures, Inc. | NKB | Class II | |
| K143088 | GastriSail Gastric Positioning System | Medtronic, Inc. | KNT | Class II | |
| K143015 | Hospira Primary Sets | Abbott Medical | FPA | Class II | |
| K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | HRS | Class II | |
| K141506 | MCC Para-Fix CARY BLAIR MEDIUM | Medical Chemical Corporation | JSM | Class I | |
| K150336 | Photonica Professional | Ward Photonics, LLC | GEX | Class II | |
| K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | LLZ | Class II | |
| K143123 | Synergetics PHOTON EX | Synergetics Inc | MPA | Class II | |
| K142956 | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit | Integrated Healing Technologies | OMP | Class II | |
| K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | |
| K142848 | Eazy Primer | Parkell, Inc. | KLE | Class II | |
| K142479 | Megna Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | |
| K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | Medtronic, Inc. | JOH | Class II | |
| K141694 | Aesculap Orthopilot Next Generation | Aesculap Inc | OLO | Class II | |
| K141657 | Thd Revolution | Thd SpA | JAF | Class II | |
| K141504 | T-8000 Therozone Unit | Therozone USA, Inc. | EIA | Class I | |
| K150166 | Extremity Medical Suture Anchor | Extremity Medical, LLC | MBI | Class II | |
| K150121 | Zimmer Periarticular Plating System | Zimmer GmbH | HRS | Class II |