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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K160253 | Vitalograph Model 6300 micro | Vitalograph Ireland Ltd. | BZG | Class II | |
| K160106 | Luna Dental Implant System | Shinhung MST Co., Ltd. | DZE | Class II | |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | IMG | Class II | |
| K153509 | GPS Angled Abutment | Implant Direct Sybron Manufacturing LLC | NHA | Class II | |
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | GXI | Class II | |
| K152197 | Skypro, SP01 Mask | Skypro Medical Supplies Company | FXX | Class II | |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | DYW | Class II | |
| K161516 | G Surgical Marksman MIS System | G Surgical Co., Ltd. | NKB | Class II | |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | Euroimmun US Inc. | LSR | Class II | |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | ERL | Class II | |
| K161355 | invendoscopy E200 System | Invendo Medical GmbH | FDF | Class II | |
| K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | MAX | Class II | |
| K161195 | Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) | M3 Global Enterprises, LLC | HIS | Class II | |
| K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | |
| K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K160764 | AirLife Autofill Humidification Chamber | Medtronic, Inc. | BTT | Class II | |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | Diasorin Inc. | LOL | Class II | |
| K160455 | AneurysmFlow | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K160379 | Exufiber Ag+ | Molnlycke Health Care, US LLC | FRO | Unclassified | |
| K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | FPA | Class II | |
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group Ltd. | DCF | Class II | |
| K153494 | HQS Introducer (Model 2064-HQS) | Alseal | DYB | Class II | |
| K152659 | V10 | Mediana Co., Ltd. | DXN | Class II | |
| K161772 | FFRct | Heartflow, Inc. | PJA | Class II | |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | PND | Class II | |
| K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K161130 | ResolutionMD | Calgary Scientific, Inc. | LLZ | Class II | |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | NDN | Class II | |
| K160802 | Infrared Forehead Thermometer, FT-100A | Hangzhou Universal Electronic Co., Ltd. | FLL | Class II | |
| K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | MAX | Class II | |
| K161663 | sTMS mini | eNeura Inc | OKP | Class II | |
| K161615 | Accurett | H&o Equipments Inc. | GEH | Class II | |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | KLW | Class II | |
| K161092 | GalaSHAPE 3D | Tepha, Inc. | OOD | Class II | |
| K160702 | ZION Anterior Cervical Fixation System | Astura Medical | KWQ | Class II | |
| K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Toshibamedical Systems Corporation | LNH | Class II | |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | KMF | Class I | |
| K153476 | KATANA AVENCIA Block | Kuraray Noritake Dental, Inc. | EBF | Class II | |
| K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | GEI | Class II | |
| K161766 | PathLoc-L MIS Spinal System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | NKG | Class II | |
| K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | Joowon Innovation Co., Ltd. | LPL | Class II | |
| K160011 | H-Max S stem | Lima Corporate S.p.A. | MEH | Class II | |
| K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | EBZ | Class II | |
| K151458 | Double Medical Universal Spine System | Double Medical Technology Inc. | MNI | Class II | |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | POM | Class II | |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | MEG | Class II | |
| K161405 | Valeo II Interbody Fusion Device System | Amedica Corp. | MAX | Class II | |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | Medtronic, Inc. | DQO | Class II | |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic, Inc. | LDF | Class II |