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 |
|---|---|---|---|---|---|
| K183585 | Elitone Device | Elidah | QAJ | Class II | |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | Titan Spine, LLC | ODP | Class II | |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use | Ezisurg Medical Co., Ltd. | GDW | Class II | |
| K183409 | Athena II Cervical Plate System | Medyssey USA | KWQ | Class II | |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co Ltd | FGE | Class II | |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | MDB | Class I | |
| K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | KWQ | Class II | |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty Limited | JDI | Class II | |
| K180691 | TrueDorsal Devices | True Function Laboratory Inc | LRK | Class II | |
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | JIF | Class I | |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Eastman Kodak Company | MQB | Class II | |
| K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 | Shanghai United Imaging Healthcare Co., Ltd. | MOS | Class II | |
| K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | LZO | Class II | |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | The Argen Corporation | EIH | Class II | |
| K182040 | Coala Heart Monitor | Coala Life AB | DXH | Class II | |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical Inc. | FDX | Class II | |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | HKX | Class II | |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I. Inc. | LDP | Class II | |
| K190035 | Biomet Headless Compression and Twist-Off Screws | Zimmer GmbH | HWC | Class II | |
| K183331 | Parcus GFS BTB | Parcus Medical, L.L.C. | MBI | Class II | |
| K183235 | SonoSite SII Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | OTN | Class II | |
| K183118 | dpl SpotLite | LED Technologies, Inc. | OLP | Class II | |
| K182417 | ROSA ONE Brain Application | MedTech LLC | HAW | Class II | |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | ACell, Inc | FTM | Class II | |
| K182224 | SafeAir Smoke Evacuator compact | LiNA Medical Inc | FYD | Class II | |
| K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | Alcon Laboratories | LPL | Class II | |
| K183659 | Omnia Medical Rotary PLIF System | Omnia Medical | MAX | Class II | |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | Globus Medical, Inc. | OUR | Class II | |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System | Medtronic Sofamor Danek USA Inc | KWQ | Class II | |
| K182796 | WavelinQ 4F EndoAVF System | C.R. Bard Inc | PQK | Class II | |
| K182102 | Rhino-Laryngo Videoscope Olympus Enf-Vh2, Rhino-Laryngo Videoscope Olympus Enf-V4 | Olympus Medical Systems Corp. | EOB | Class II | |
| K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | CCK | Class II | |
| K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K183388 | JADE Mobile X-Ray | DRGEM Corporation | IZL | Class II | |
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Motiva USA, LLC | MRD | Unclassified | |
| K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | O&M Halyard, Inc. | LZC | Class I | |
| K183081 | Spectra Optia Apheresis System | Terumobct, Inc. | LKN | Unclassified | |
| K182170 | PRECICE® BONE TRANSPORT™ System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K181142 | Absoanchor Microimplant | Dentos, Inc. | OAT | Class II | |
| K190067 | Velofix Interbody Fusion System | CG MedTech Co., Ltd. | ODP | Class II | |
| K183571 | Capture-CMV | Immucor, Inc. | LJO | Class II | |
| K183499 | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | MAX | Class II | |
| K181916 | d-Nav System | Hygieia, Inc. | NDC | Class II | |
| K190053 | SECULOK™ ACP System | CG MedTech Co., Ltd. | KWQ | Class II | |
| K183452 | Vbeam Prima Laser System | Candela Corporation | GEX | Class II |