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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K182642 | GenesisZr™ 4Y Zirconia | United Dental Resources Corporation | EIH | Class II | |
| K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | BSK | Class II | |
| K182480 | Earlens Contact Hearing Aid | Earlens Corporation | PLK | Class II | |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | JKA | Class II | |
| K180780 | microINR System | Iline Microsystems S.L. | GJS | Class II | |
| K180230 | NEST Interbody System | Paonan Biotech Co., Ltd | MAX | Class II | |
| K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | KPR | Class II | |
| K183346 | FLOW 90 Wand | ArthroCare Corporation | GEI | Class II | |
| K183244 | MAGNETOM Lumina | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K182594 | E-CUBE i7 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | FXX | Class II | |
| K182363 | Btl-703 | BTL Industries, Inc | IMJ | Class II | |
| K182312 | Zyppah Anti-Snoring Device | Always More Marketing Inc | LRK | Class II | |
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | DRG | Class II | |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | LCM | Unclassified | |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions | NLH | Class II | |
| K180183 | Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | DZE | Class II | |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group Ltd. | CFN | Class II | |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies ULC. (Now A Part of Stryker) | IZI | Class II | |
| K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | DQA | Class II | |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc | MIB | Class II | |
| DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | QEP | Class II | |
| K183685 | O-Scan | Esaote S.p.A. | LNH | Class II | |
| K183671 | Lg Pra.l Derma LED Mask | LG Electronics.Inc | OHS | Class II | |
| K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | Boston Scientific Corporation | FBN | Class II | |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | Zimmer GmbH | MBF | Class II | |
| K182970 | EUROPA™ Pedicle Screw System | Mirus, LLC | NKB | Class II | |
| K182955 | EZStart Interference Screw | ConMed Corporation | HWC | Class II | |
| K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K182837 | M.U.S.T. Mini Extension | Medacta International SA | NKG | Class II | |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics Inc. | JWH | Class II | |
| K182193 | S-Line | Biocetec Co., Ltd. | NJM | Class II | |
| K181887 | AMD Anti-Fog Solution | Advanced Medical Design Co., Ltd. | OCT | Class II | |
| K180767 | FEMON Banana Thermometer | Life Science Technology, Inc. | FLL | Class II | |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | PDU | Class II | |
| K182507 | Tigon Medical Tissue Anchors | Tigon Medical LLC | MBI | Class II | |
| K183581 | Codman Disposable Perforators | Integra LifeSciences Corporation | HBF | Class II | |
| K182527 | ELAN 4 Tools | Aesculap Inc | HBE | Class II | |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | Hardy Diagnostics | JTN | Class II | |
| K183264 | Flex-THOR scope | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K183254 | Magnetom Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K183231 | SIGNA Premier | GE Healthcare | LNH | Class II | |
| K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical, Inc. | NAY | Class II | |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical, Ltd. | BTL | Class II | |
| K182951 | Pristina Serena 3D | GE Healthcare | MUE | Class II | |
| K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | QAZ | Class II | |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | Alcon Laboratories | LPL | Class II | |
| K182620 | MRI Compatibility for Existing Neodent Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II |