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 |
|---|---|---|---|---|---|
| K002335 | Natural-Knee II System-Durasul Tibial Insert and Durasul All-Poly Patella | Sulzer Orthopedics, Inc. | JWH | Class II | |
| K002310 | Cardiobeeper Cb12/12, Model Cb12/12 | Meridian Medical Technologies, Ltd. | DXH | Class II | |
| K001884 | Direct Crown | Flexible Dimensions, LLC | EBG | Class II | |
| K001811 | Neu-Ion Hemodialyis Water Treatment System | Neu-Ion, Inc. | FIP | Class II | |
| K001493 | Dental Air Force Home Dental Cleaning System, Model No. 0020001 | Air Force, Inc. | EFS | Class I | |
| K001295 | Piper | Rtek Medical Systems, LLC | MUJ | Class II | |
| K001096 | Burr Hole Cover, Model Xx | Image-Guided Neurologics, Inc. | GXR | Class II | |
| K983783 | Heated Humidifier | Pegasus Research Corp. | BTT | Class II | |
| K003152 | Somatom Smile | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K003091 | Medline Sterile Vinyl Exam Gloves, Powder Free, Yellow | MEDLINE INDUSTRIES, LP - Northfield | LYZ | Class I | |
| K002975 | Dermagrip Powder Free Polymer Coated Latex Examination Glove Sterile, Contains 50 Micrograms or Less of Total Extractabl | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | |
| K002903 | Anspach Angled Micronose Attachment | The Anspach Effort, Inc. | HBE | Class II | |
| K002826 | Equity | Jensen Industries, Inc. | EJT | Class II | |
| K002492 | Simplicity Soft Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | GCJ | Class II | |
| K002284 | Venture Idd Oxygen Conserving Device Idd 20Ex and 50Ex | Invacare GmbH | NFB | Class II | |
| K001693 | Life Scope P, Model Bsm-4100 Series | Nihon Kohden America Inc | MHX | Class II | |
| K001070 | Radiomed Source | Radiomed Corporation | KXK | Class II | |
| K000739 | Evantgarde/endeavor Powered Wheelchair | Otto Bock Orthopedic Industry, Inc. | ITI | Class II | |
| K000418 | Pdt Dosecalculator, Model 80000 | Retinalabs.Com | NDC | Class II | |
| K993094 | Aero-Click | Map Medizintechnik Fur Arzt und Patient GmbH | BZD | Class II | |
| K002980 | Modification to Ebi Anterior Cervical Plate System | Ebi, LLC | KWQ | Class II | |
| K002943 | Wheelchair, Mechanical Series Model 3100 | Mada Medical Products, Inc. | IOR | Class I | |
| K002788 | Ksea Neuro-Fiberscope | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K002773 | Neuromap with Neuro 100 | Radionics, Inc. | GWF | Class II | |
| K002631 | Electroencephalograph Software Eemagine EEG | Eemagine Medical Imaging Solutions GmbH | OLX | Class II | |
| K002622 | Biosleep | Oxford Biosignals Limited | OLZ | Class II | |
| K002589 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | LPN | Class II | |
| K002542 | Reusable Cannula | Genicon, LC | GCJ | Class II | |
| K002500 | X-Posure System Version 2 Rad | Pronosco A/S | KGI | Class II | |
| K002446 | Re-Entrant Chamber, Model 1008 or 44D | Sun Nuclear Corporation | KXK | Class II | |
| K002389 | Baylis Pain Management Probe/pmp-20-145 and Baylis Pain Management Connector Cable/pmx-Bay-Bay | Baylis Medical Co., Inc. | GXI | Class II | |
| K002341 | Thermal Cautery Unit, Model 150 | Geiger Medical Technologies, Inc. | HQO | Class II | |
| K002278 | Brooker Femoral Nails | Biomet Orthopedics, Inc. | HSB | Class II | |
| K002261 | Mr-III | Smith & Nephew, Inc. | GAS | Class II | |
| K001990 | Depilase Yaglase Nd:yag Laser System and Accessories | Depilase Group, Ltd. | GEX | Class II | |
| K001741 | Radionics RF Disc Catheter Electrode System | Radionics, Inc. | HRX | Class II | |
| K001468 | Elecsys Ca 15-3 Test System | Roche Diagnostics GmbH | MOI | Class II | |
| K001163 | Dmlc IV-Ergo | 3D Line USA, Inc. | IXI | Class II | |
| K000838 | Digitcare Powder Free Coated Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | P.T. Healthcare Glovindo | LYY | Class I | |
| K994320 | Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses | Cantor & Silver, Ltd. | NCZ | Class II | |
| K994281 | Biopro, Nitrile, Correct Touch Nitrile Powder Free Examination Gloves (Grren, Purple) | Biopro (M) Sdn Bhd | LZA | Class I | |
| K994276 | Biopro, Nitrilon, Correct Touch- Nitrile Powdered Examination Gloves (Green/ Purple) | Biopro (M) Sdn Bhd | LZA | Class I | |
| K991124 | Visijet Hydrokeratome, Model 50 | Visijet, Inc. | MYD | Class I | |
| K003125 | Sonoline Elegra Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K003121 | Mysono 201 Diagnostic Ultrasound and Transducers | Medison America, Inc. | IYO | Class II | |
| K003104 | Bact/alert Csr | bioMerieux, Inc. | LJF | Class I | |
| K002949 | Modification to Datascope Profile 8Fr. Iab, 34Cc; Modification to Datascope Profile 8Fr. Iab, 40Cc | Datascope Corp. | DSP | Class II | |
| K002888 | Nichols Advantage Thyroglob | Nichols Institute Diagnostics | MSW | Class II | |
| K002814 | Disposbable Powdered Vinyl Synthetic Exam Gloves, White Color | Shanghai PM Plastics Enterise Co., Ltd. | LYZ | Class I |