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 |
|---|---|---|---|---|---|
| K083816 | Res Traxx Online, Model: R14 | ResMed Corp | BZD | Class II | |
| K083802 | Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025 | Medi-Globe GmbH | FCG | Class II | |
| K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | Bien-Air Surgery SA | ERL | Class II | |
| K083493 | Myoscience Cryo-Touch | Myoscience, Inc. | GEH | Class II | |
| K083425 | Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage | Adaptive Specialty, LLC | ODP | Class II | |
| K083341 | Nuvasive Helix-T Acp System | NuVasive Inc | KWQ | Class II | |
| K082819 | Dermatologic Treatment System (Dts) G2 | miraDry, Inc. | NEY | Class II | |
| K082689 | Sterile Sodium Chloride 0.9% Flush, 5Ml, 10Ml, Ampule | Spectra Medical Devices, LLC | NGT | Class II | |
| K082147 | Bodymetrix Bx2000 | Intelametrix, Inc. | OMV | Class II | |
| K082039 | Synchro Hp Platform | El.en. Electronic Engineering SpA | GEX | Class II | |
| K081269 | Avie A1c Test System | Mec Dynamics Corp | LCP | Class II | |
| K090537 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Jiteng Plastic Products Co., Ltd. | LYZ | Class I | |
| K090524 | Go Go Elite Traveler V Three Wheel Scooter, Model Sc40ev | Pride Mobility Products Corp | INI | Class II | |
| K090481 | Demasq Imaging Spftware Device | Demasq Limited | LLZ | Class II | |
| K090128 | Tac-Tite (Tm) | Core Essence Orthopaedics, LLC | GAT | Class II | |
| K090108 | Hoveround Teknique Fwd Mk4 Power Wheelchair | Hoveround Corp. | ITI | Class II | |
| K083892 | Fore-Sight, Model Mc-2000 Series (Mc-2000, Mc-2010, Mc2020, Mc2030) | Cas Medical Systems, Inc. | DQA | Class II | |
| K083873 | Picc (CT Rated and Non-Rated) | PFM Medical GmbH | LJS | Class II | |
| K083825 | Eoi Spinal System | Expanding Orthopedics, Inc. | NKB | Class II | |
| K083801 | Bactrack Select Breathalyzer, Models S30, S50, S70 | KHN Solutions LLC | DJZ | Class I | |
| K083697 | Fukuda Denshi Dynascope Model Ds-7000 Series Patient Monitor, Model Ds-7000//7000M/7210/7210m | Fukuda Denshi USA, Inc. | MHX | Class II | |
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard Inc | NIE | Class II | |
| K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | MNR | Class II | |
| K082594 | Remesense | Remedent NV | LBH | Class II | |
| K081835 | Acticare Ic and Tse | Bioinduction Limited | GZJ | Class II | |
| K081424 | Affirm CO2 and Affirm CO2 Hp | Cynosure, LLC | GEX | Class II | |
| K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | KCT | Class II | |
| K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017U | C.R. Bard Inc | NEU | Class II | |
| K090272 | Spetzler Scalp Retractor Clamps (Various Styles and Sizes) | Medtronic, Inc. | GZT | Class II | |
| K090137 | Stak-Chex Plus Retics | Streck LLC | GLQ | Class II | |
| K083909 | Spinal Injection System | Laurimed, LLC | BSP | Class II | |
| K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | FTM | Class II | |
| K083688 | Pulmonetic Systems Ltv 1200 Mr Conditional Ventilator | Pulmonetic Systems, Inc. | CBK | Class II | |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685 | Biopro, Inc. | HTY | Class II | |
| K083444 | C-Reactive Protein (Latex) | Roche Diagnostics GmbH | DCN | Class II | |
| K083433 | Intelect Swd 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group, Inc. | IMJ | Class II | |
| K081615 | Olympus Cea - Carcinoembryonic Antigen | OLYMPUS Corporation of the Americas | DHX | Class II | |
| K081554 | Tokuyama Tissuecare | Tokuyama Dental Corporation | EBI | Class II | |
| K090322 | Easy Moving Plus, Sm-Xxhf-Yy | Sedecal S.A. | IZL | Class II | |
| K090235 | Elite Mpx Laser System with Xpl Handpiece | Cynosure, LLC | GEX | Class II | |
| K090141 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | FRO | Unclassified | |
| K090076 | Salto Talaris Total Ankle Prosthesis | TORNIER Inc. | HSN | Class II | |
| K083858 | Bond Bone | Augma Biomaterials | LYC | Class II | |
| K083478 | Smoothlipo | Eleme Medical, Inc. | GEX | Class II | |
| K090597 | Fluorilaq Sodium Fluoride Cavity Varnish | Pascal International, Inc. | LBH | Class II | |
| K090590 | Veradius, Model 718-130 | Philips North America LLC | OWB | Class II | |
| K090552 | Urocare | Neusoft Medical Systems Co., Ltd. | LLZ | Class II | |
| K090514 | Verify Self-Contained Biological Indicator for Vaporized (Vh2o2) Sterilization Processes | STERIS Corporation | FRC | Class II | |
| K090267 | Sv Dbs Brain Array, Model 1500Sv-Sms64 | Midwest Rf, LLC | MOS | Class II | |
| K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II |