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 |
|---|---|---|---|---|---|
| K052777 | Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo Lp1rg-S, Lp1rg-D | Ellex Medical Pty Ltd | GEX | Class II | |
| K052598 | Immocare | Care Diagnostic, Inc. | KHE | Class II | |
| K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research SRL | BZG | Class II | |
| K051675 | Biodynamics Bia 500 Biompedance Body Composition Analyzer | Biodynamics Corp. | MNW | Class II | |
| K050239 | Emd Thermography System | Em Diagnostics, Inc. | LHQ | Class I | |
| K060572 | Modification to Polarcath Peripheral Dilatation System | Boston Scientific Corporation | DQY | Class II | |
| K060429 | Tdm Control Set | Roche Diagnostics GmbH | JJY | Class I | |
| K060418 | 8F Sherpa Nx Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K060401 | Medrad 3.0T Ecoil Imaging System | Medrad, Inc. | MOS | Class II | |
| K060360 | Howmedica Osteonics Modular Rotating Hinge Knee with Offset Adapters | Howmedica Osteonics Corp | KRO | Class II | |
| K060328 | Planmeca Promax 3D | Planmeca Oy | MUH | Class II | |
| K060263 | Iqpacs | S.C. Info World S.r.l. | LLZ | Class II | |
| K060234 | Mccue Energist Ultra Vpl Intense Pulse Light System | Mccue PLC | GEX | Class II | |
| K060229 | Powder-Free Black Latex Examination Gloves with Protein Labeling (50 Micrograms or Less of Total Water Extractable Prote | Shun Thai Rubber Gloves Industry Public Co., Ltd. | LYY | Class I | |
| K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | IYE | Class II | |
| K060104 | Prismatik Clinical Zirconia | Glidewell Laboratories | EIH | Class II | |
| K060102 | Synergeyes Ps Hybrid Contact Lens | Synergeyes, Inc. | HQD | Class II | |
| K053622 | Surgisis Ocular Graft | Iop, Inc. | NXM | Class II | |
| K053611 | Smoothshapes | Bicellulase, Inc. | NUV | Class II | |
| K053507 | Elite Electromed L.i.t.e. 4/1 | Elite Electromedical | NHN | Class II | |
| K053498 | Hyperox 101 | Wjo, Inc. | CBF | Class II | |
| K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology Ltd. | KPI | Class II | |
| K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Medtronic, Inc. | GEI | Class II | |
| K052555 | Medtronic Performer Tm Cpb, Model R51, Pcpb | Rand S.r.l. | DTQ | Class II | |
| K052310 | Cryoflow 700, Cryoflow 1000 | Uniphy Elektromedizin GmbH & Co. KG | GEX | Class II | |
| K060504 | Ideal Life Bp-Manager, Model Bpm 0001; Ideal Life Pod, Model Ilp 0001 | Ideal Life, Inc. | DXN | Class II | |
| K060368 | Inspirstar Is02 Microcurrent Stimulator | Inspirstar, Inc. | GZJ | Class II | |
| K060076 | Surgicount Safety-Sponge System | Surgicount Medical | LWH | Class I | |
| K053636 | Mani Needle & Suture Pack (Pga Absorbable) | Mani, Inc. | GAM | Class II | |
| K053616 | Polaris Wr, St Applicator | Syneron Medical, Ltd. | GEX | Class II | |
| K053355 | Bti Interna Dental Implant System | B.T.I. Biotechnology Institute, S.L. | DZE | Class II | |
| K053255 | Nexus Ligating Clip | Microsurgical Laboratories,Inc.Dba Wexler Surgical | FZP | Class II | |
| K060534 | Intuitive Surgical Seal | Applied Medical Resources Corp | GCJ | Class II | |
| K060491 | Quantum Anterior Cervical Plate System | Quantum Orthopedics, Inc. | KWQ | Class II | |
| K060419 | Concerto Bipolar Needle Electrode | Boston Scientific Corporation | GEI | Class II | |
| K060393 | Inion Hexalon Biodegradable Acl/pcl Screw | Inion Oy | HWC | Class II | |
| K060373 | Cobas 6000 Series System | Roche Diagnostics GmbH | CEM | Class II | |
| K060148 | Ebi Vertebroplasty Systems | Ebi, LLC | NDN | Class II | |
| K053653 | Fidis Connective 10, Model Mx006 | Biomedical Diagnostics (Bmd) SA | LLL | Class II | |
| K053291 | Ferritin Calibrator Set, Catalog No. 8203 | Reference Diagnostics, Inc. | JIT | Class II | |
| K053268 | Pvs 2000 Synchro2 Guidewire | Boston Scientific - Precision Vascular | DQX | Class II | |
| K053211 | Rdi Hsferritin Kit | Reference Diagnostics, Inc. | DBF | Class II | |
| K052567 | One Tray Sealed Sterilization Container | Sterile Containment Technology, LLC | KCT | Class II | |
| K051875 | Bioflex Prescription System and Related Treatment Heads | Meditech International Inc | ILY | Class II | |
| K051596 | Statusfirst Chf (Congestive Heart Failure) Nt-Probnp, Model 20204 | Nanogen, Inc. | NBC | Class II | |
| K060513 | Sintea Biotech Pls Multi-Axial Screws, Model Pls.xx.t5.x | Sintea Biotech, Inc. | KWP | Class II | |
| K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | MQB | Class II | |
| K060349 | Proguide Needle Set | Nucletron BV | JAQ | Class II | |
| K060208 | Careo Safety Syringe 1Cc/ml, Models Ca0106-C,ca0196-C,ca0186-C,ca0107-C,ca0197-C,ca0187-C,ca0104-C,ca0194-C,ca0184-C, | Life-Shield Products, Inc. | MEG | Class II | |
| K060178 | Vix Win Pro | Gendex Corp. | MUH | Class II |