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 |
|---|---|---|---|---|---|
| K050951 | Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360; Medstar 370, Model 533-370 | Cibernet Systems Corp. | DXH | Class II | |
| K050417 | Elite Implant | Zhermack S.p.A. | ELW | Class II | |
| K050210 | Disposable Cement Spacer Molds for Temporary Knee Prostheses | Zimmer GmbH | JWH | Class II | |
| K043528 | Spirotel | Mir Medical Intl. Research SRL | BZG | Class II | |
| K043032 | Dealight Ipl | Europro, Inc. | GEX | Class II | |
| K042583 | Calc-I-Oss | Ultradent Products Inc. | LYC | Class II | |
| K041342 | Impruv A.i. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | MGQ | Unclassified | |
| K051673 | Xeleris 2 Processing and Review Workstation | GE Healthcare | LLZ | Class II | |
| K051545 | L.e. Demetron II | Kerr Corporation (Danbury) | EBZ | Class II | |
| K051497 | Vitesse 2.0 | Varian Medical Systems, Inc. | MUJ | Class II | |
| K051430 | Extreme H2o 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) | Hydrogel Vision Corporation | LPL | Class II | |
| K051316 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard Inc | LJE | Unclassified | |
| K050739 | Codman Vpv System, Model 82-3192 | Cerenovus, Inc. | JXG | Class II | |
| K051833 | Tsx-101A/h Aquilion 64 Sp CT Scanner; Tsx-101A/i Aquilion 32 Sp CT Scanner | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K051723 | Powder-Free Vinyl Patient Examination Gloves (White, Yellow) | Zibo Sinocare Plastic Products Co., Ltd. | LYZ | Class I | |
| K051707 | Eclipse Bonding Agent | Dentsply Intl. | KLE | Class II | |
| K051635 | Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-Nmt and Accessories | GE Healthcare | KOI | Class II | |
| K051439 | Lnop Blue Oximetry Sensor | Masimo Corporation | DQA | Class II | |
| K051424 | Hydrogum 5 | Zhermack S.p.A. | ELW | Class II | |
| K051381 | Ace Surgicalplaster Calcium Sulface Hemihydrate | Ace Surgical Supply Co., Inc. | LYC | Class II | |
| K051314 | Res Traxx Data Center | ResMed Corp | BZD | Class II | |
| K051253 | Modification to: Multirate Infusor Sv )with and without Pcm), Multirate Infusor Lv (with and without Pcm) | Baxter Healthcare Corporation | MEA | Class II | |
| K051062 | Vp Wire Gw140st (.014 165Cm, Standar), Model Gw140st; Vp Wire Gw140so (.014 165Cm, Soft) Model Gw140so | Flowcardia, Inc. | DQX | Class II | |
| K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | GZI | Class II | |
| K050785 | Amsino Endotracheal Tube | Amsino International, Inc. | BTR | Class II | |
| K050260 | Bioresorb Macro Pore | Oraltronics Dental Implant Technology GmbH | LYC | Class II | |
| K043406 | Vertebroplastic Radiopaque Bone Cement | DePuy Spine, Inc. | NDN | Class II | |
| K051795 | Nomad Dental X-Ray System | KaVo Dental Technologies, LLC | EHD | Class II | |
| K051765 | Ceretom, Model Nl3000 | Samsung HME America, Inc. | JAK | Class II | |
| K051763 | Qd Knee/foot Coil, Model Mjqj-147A | Toshiba America Medical Systems, In.C | MOS | Class II | |
| K051745 | Echosystem | Medstrat | LLZ | Class II | |
| K051692 | Bd Phoenix Automated Microbiology System - Amoxicillin (Strep) 0.0313 - 32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051686 | Cardiomem Cm 3000-12 | Getemed Medizin- und Informationstechnik AG | MWJ | Class II | |
| K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corporation | OBJ | Class II | |
| K051625 | Barrier Surgical Drapes | Molnlycke Health Care | KKX | Class II | |
| K051547 | Powermax 25, Model Pm25; Powermax 30, Model Pm30 | TPC Advanced Technology, Inc. | ELC | Class II | |
| K051446 | Femtex and Private Label Opal Fresh Scented Plastic Applicator Tampons | First Quality Hygienic, Inc. | HIL | Class II | |
| K051403 | 19-Inch (48Cm) Color Lcd Monitor Cdl1904a | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050992 | Conmed Irrigation Nozzle | Conmedcorp | KPL | Class II | |
| K050848 | Tornier Elbow Prosthesis | TORNIER Inc. | JDB | Class II | |
| K050620 | Readmyheart, Model Rmh3.0 | Dailycare Biomedical, Inc. | DPS | Class II | |
| K050410 | Hes Ultrasonic Therapy Appliance, Models Hs-3008 (1Mhz), Hs3026 (2Mhz), Hs-3040 (3Mhz) | Hwang Sun Enterprise Co., Ltd. | IMI | Class II | |
| K051776 | Protege Ultrasonic Insert | Discus Dental LLC | ELC | Class II | |
| K051764 | T-Plate Anterior Fixation System | Esm Technologies | KWQ | Class II | |
| K051659 | Semial Spinal Implant | Signus Medizintechnik GmbH | MQP | Class II | |
| K051549 | Cardius-1, Cardius-2, Cardius-3, 2020Tc Spect Imaging System | Digirad Corp. | KPS | Class II | |
| K051359 | Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory | Candela Corporation | GEX | Class II | |
| K051146 | Triathlon Knee System | Howmedica Osteonics Corp | JWH | Class II | |
| K051142 | Angiodynamics Tumescent Infusion Device | Boston Scientific Corporation | FPA | Class II | |
| K051049 | Synthes (USA) Low-Profile Wrist Fixator | Synthes (USA) Products LLC | KTT | Class II |