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 |
|---|---|---|---|---|---|
| K073697 | Transbond Supreme Adhesive | 3M UNITEK Corporation | DYH | Class II | |
| K073588 | Gc Models Opa-100 and Jc-50 | GC America Inc. | DYH | Class II | |
| K073282 | Biohorizons Single-Stage Implant System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K073245 | Extended Vertiflex Spinal Screw System | Vertiflex, Inc. | NKB | Class II | |
| K073076 | Hoffmann Light System | Howmedica Osteonics Corp | KTT | Class II | |
| K073067 | Ankylos Dental Implant System/claims | Dentsply International, Inc. | DZE | Class II | |
| K072856 | Spi Variomulti Abutment | Thommen Medical AG | NHA | Class II | |
| K072733 | 3M Espe Adult Crown | 3M Company | EBF | Class II | |
| K072447 | Pentaborn | Mediscitec, Inc. | DZE | Class II | |
| K072382 | Model I-2000 Monitor | Infinite Biomedical Technologies, LLC | OLT | Class II | |
| K072227 | Vinyl Examination Glove Powder Free | Pinnacle Co., Ltd | LYZ | Class I | |
| K071702 | Breas Vivo Bilevel System, Model Vivo 40 | Breas Medical AB | MNT | Class II | |
| K071663 | Vf Gel Plus | Coapt Systems, Inc. | MIX | Class II | |
| K071596 | Potable Air Massager Putifino, Model Am-7 | Nihon Seimitsu Sokki Co., Ltd. | IRP | Class II | |
| K062991 | Gentlewaves Consumer LED Photomodulation Device | Light Bioscience, LLC | OHS | Class II | |
| K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | IYO | Class II | |
| K080143 | Modification to Stryker Spine Oasys System | Howmedica Osteonics Corp | MNI | Class II | |
| K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-Xx | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K073602 | Modification to: Apex Knee System | Omnlife Science | JWH | Class II | |
| K073542 | Cycletrac CT-5000 | Pt Products, LLC | ITH | Class II | |
| K073527 | Variax Elbow System | Howmedica Osteonics Corp | KTT | Class II | |
| K073420 | Blackstone Ascent Multiaxial Screws | Blackstone Medical, Inc. | KWP | Class II | |
| K073419 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization Particles | Rj Medical, Inc. | HCG | Class II | |
| K073332 | V-Raser Diode Laser System | Hoya Conbio, Inc. | GEX | Class II | |
| K073263 | Pro-V | Bisco Inc | EBG | Class II | |
| K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon Implants, Atlantis Gemini + Abutment | Atlantis Components, Inc. | NHA | Class II | |
| K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools | Cardiovascular Imaging Solutions, Ltd. | LLZ | Class II | |
| K073154 | Facts Hand and Pinch Grip Combo | Global Services Group, LLC | LBB | Class II | |
| K073079 | Thumper, Model: 1008 | Michigan Instruments | DRM | Class II | |
| K073007 | Coronis Fusion 6Mp Dl, Model: Mdcc 6130 Dl | Barcoview, Medical Imaging Systems | LLZ | Class II | |
| K072107 | Perioscan, Model: D 3496 | Sirona Dental Systems GmbH | ELC | Class II | |
| K072100 | Gc Aadva Abutment | GC America Inc. | NHA | Class II | |
| K070947 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe Grasper | Intuitive Surgical, Inc. | NAY | Class II | |
| K080111 | Arthrex Compression Staple | Arthrex GmbH | JDR | Class II | |
| K080077 | Clave Stopcock | Abbott Medical | FMG | Class II | |
| K080069 | Dimertest | Sekisui Diagnostics, LLC | DAP | Class II | |
| K073669 | Oria Natura Spacer | Choicespine, LP | MAX | Class II | |
| K073437 | Thor Anterior Plating System | Howmedica Osteonics Corp | KWQ | Class II | |
| K073349 | Reliance Buttress Washer System | Reliance Medical Systems, LLC | KWQ | Class II | |
| K073337 | Mectacer Biolox Forte-Femoral Heads | Medacta International SA | LZO | Class II | |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care (21-6276) | Abbott Medical | MRZ | Class II | |
| K072487 | Fast1 Intraosseous Infusion System | Pyng Medical Corp. | FMI | Class II | |
| K073613 | Reprocessed Scissor Tips | Sterilmed Inc | NUJ | Class II | |
| K073145 | Quanta Lite H-Ttg Screen | Inova Diagnostics, Inc. | MVM | Class II | |
| K073073 | Ankylos Temporary Abutment Balance | Dentsply International, Inc. | NHA | Class II | |
| K072609 | Single Step Medium | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K072563 | Miltex Rigid Container Systems | Miltex, Inc. | KCT | Class II | |
| K072494 | Ag-Classic | Medel S.p.A. | CAF | Class II | |
| K072409 | Afinion Acr and Acr Control | Axis-Shield Poc AS | JFY | Class II | |
| K071432 | Silverhawk-R Peripheral Plaque Excision System for Surgical Use | Medtronic, Inc. | MCW | Class II |