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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K142392 | Zavation Posterior LEIF | Zavation | MAX | Class II | |
| K142153 | Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3Ml;5ml;15ml | Teleflexmedical, Inc. | CAF | Class II | |
| K142073 | St'rim | Thiebaud SAS | MUU | Class II | |
| K141984 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K150842 | JUSHA-M53 Medical Display | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K150460 | KYPHON (R) HV-R(R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | NDN | Class II | |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | KWP | Class II | |
| K150223 | Facet-Link Stabilization Platform | Facet-Link, Inc. | MRW | Unclassified | |
| K150059 | BD FlowSmart Set | Becton Dickinson & Co | FPA | Class II | |
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Sonoscape Company Limited | IYN | Class II | |
| K143551 | Compex Wireless USA | DJO, LLC | NGX | Class II | |
| K143024 | CAS-One Liver | Cascination | OEW | Class II | |
| K142196 | Visage Ease Pro | Visage Imaging, Inc | LLZ | Class II | |
| K150286 | Medline Enteral Feeding Sets | MEDLINE INDUSTRIES, LP - Northfield | PIF | Class II | |
| K150843 | syngo®.via (version VB10A) | Siemens Corp. | LLZ | Class II | |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co.,Ltd. | EFB | Class I | |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific LLC | DIS | Class II | |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | SPINEFRONTIER, Inc. dba LESspine Innovations | OUR | Class II | |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | OLI | Class II | |
| K143530 | Aespire View | GE Healthcare | BSZ | Class II | |
| K143238 | C3 Wave | Medcomp ( Medical Components) | LJS | Class II | |
| K142918 | EndoTool SubQ | Monarch Medical Technologies | NDC | Class II | |
| K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | EOQ | Class II | |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corp. | GWF | Class II | |
| K142371 | Luminesse PMMA | Talladium Inc | EBG | Class II | |
| K142061 | Silhouette Instalift | Sinclair Pharma US, Inc. | GAM | Class II | |
| K141643 | Yarlap | International Trade Group, Inc. | KPI | Class II | |
| K141482 | Ki-20 | Saeyang Microtech Co., Ltd. | EBW | Class I | |
| K150993 | NICO TRIOwand | Nico Corporation | GEI | Class II | |
| K150656 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | HSB | Class II | |
| K150583 | Aequalis PerFORM+ Shoulder System | TORNIER Inc. | KWS | Class II | |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer GmbH | JDC | Class II | |
| K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio de Materiais Dentarios S | DZE | Class II | |
| K150163 | Otowave 202 Portable Tympanometer | Amplivox Ltd | NAS | Class II | |
| K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | Hartalega Sdn Bhd | LZA | Class I | |
| K143684 | NuVasive Reline System | Nu Vasive, Incorporated | NKB | Class II | |
| K143666 | Noblex Long Pulse Alexandrite Laser | FINEMEC Co., Ltd | GEX | Class II | |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker Corp. | HBE | Class II | |
| K143280 | BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens | Brien Holden Vision Pty, Ltd. | LPL | Class II | |
| K143252 | Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) | Needle Tech Products, Inc. | DQX | Class II | |
| K142926 | iBreastExam | UE Lifesciences Inc. | NKA | Class II | |
| K142817 | IntraNovo 25 Microcatheter | Texasmedical Technologies, Inc. | DQO | Class II | |
| K142535 | ConMed Mixing and Delivery Kit | ConMed Corporation | FMF | Class II | |
| K142282 | Hummingbird(tm) Tympanostomy Tube System (Tts) | Preceptis Medical, Inc | ETD | Class II | |
| K142253 | SOLSTICE OCT System | Life Spine | KWP | Class II | |
| K142141 | Starband, Starlight | Orthomerica Products, Inc. | OAN | Class II | |
| K141362 | Pulse Oximeter Cms50ew | Contec Medical Systems Co., Ltd. | DQA | Class II | |
| K140348 | Interbody Cage | Eisertech, LLC | MAX | Class II |