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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical Ltd | PQM | Class II | |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | KNF | Class II | |
| K193228 | Hamilton-G5 | Hamilton Medical AG | CBK | Class II | |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | OKO | Class II | |
| K192887 | Revitive Medic Plus, Revitive Advanced 2 | Actegy Ltd. | NGX | Class II | |
| K183110 | Livia | Lifecare, Ltd. | NUH | Class II | |
| K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | QJP | Class II | |
| K200417 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | QJP | Class II | |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K200606 | O-Genesis Graft Delivery System | Orthofix SRL | FMF | Class II | |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart SA | NKG | Class II | |
| K200453 | Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-Ac | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | Phadia AB | DHB | Class II | |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | GCA | Class II | |
| K192656 | Optimized Positioning System (OPS) Insight | Corin USA | LLZ | Class II | |
| K192633 | GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd | CAF | Class II | |
| K192540 | Kitazato ET Catheters | Kitazato Corporation | MQF | Class II | |
| K192405 | Image Guidance System for Radiotherapy | Jiangsu Rayer Medical Technology Co., Ltd. | IYE | Class II | |
| K192295 | Pdt-Face | Beijing Adss Development Co., Ltd. | OLP | Class II | |
| K192286 | FUJIFILM EP-6000 Video Processor | FUJIFILM Corporation | FET | Class II | |
| DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics | QKV | Class II | |
| DEN180065 | OGmend Implant System | woven Orthopedic Technologies | QAC | Class II | |
| K200902 | ClickClean | Medeon Biodesign, Inc. | GCJ | Class II | |
| K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II | |
| K200523 | Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty) Ltd | KWQ | Class II | |
| K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K200240 | Turbett Instrument Pod | TURBETT SURGICAL, Inc | FRG | Class II | |
| K193523 | ArthrexVIP Web Portal | Arthrex GmbH | LLZ | Class II | |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics Ltd. | ONG | Class II | |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,Ltd. | FYA | Class II | |
| K192246 | Biowy PICC Catheter S Kit | Biowy Corporation | LJS | Class II | |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | DXG | Class II | |
| K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | JXG | Class II | |
| K200327 | Evry | Synaptive Medical Inc | LNH | Class II | |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | PHX | Class II | |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | PKC | Class II | |
| K191992 | PELNAC Bilayer Wound Matrix | Gunze Limited | KGN | Unclassified | |
| K191866 | GelPOINT Mini Advanced Access Platform | Applied Medical | GCJ | Class II | |
| K191816 | M-Vizion Femoral Revision System Extension | Medacta International SA | LZO | Class II | |
| DEN180055 | CARPEDIEM System | Bellco SRL (Now Part of Medtronic, Inc) | QIR | Class II | |
| K200896 | Solstice CCI | Life Spine | NKG | Class II | |
| K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA | DZE | Class II | |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | NKG | Class II | |
| K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | Zimmer GmbH | HSB | Class II | |
| K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | OVD | Class II |