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 |
|---|---|---|---|---|---|
| K210421 | Diafil & Diafil Capsule | Diadent Group International | EBF | Class II | |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co., Ltd. | PNR | Class II | |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | DZJ | Class II | |
| K211656 | 3D Echo v1.1 | Jointvue, LLC | LLZ | Class II | |
| K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K211252 | Nitrile Glove | Jiangsu Dihong Industry and Trade Co., Ltd. | LZA | Class I | |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Corp. | NDN | Class II | |
| K211232 | Apache Ultrasound System | Aco Healthcare Co., Ltd. | IYN | Class II | |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | IYO | Class II | |
| K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | |
| K210138 | iTind System | Medi-Tate | QKA | Class II | |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | QAU | Class II | |
| K203657 | Vu-Path Ultrasound System | Crystalline Medical | IYN | Class II | |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | Psychemedics Corp. | JXO | Class II | |
| K201196 | Scooter (Model: FDB01) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | INI | Class II | |
| K211623 | THD Procto Software System | Thd SpA | IYO | Class II | |
| K211306 | Labyrinth | Zavation Medical Products, LLC | MAX | Class II | |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | MicroAire Surgical Instruments, LLC | HRX | Class II | |
| K211259 | Renamel Bulkfill | Cosmedent, Inc. | EBF | Class II | |
| K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | OWB | Class II | |
| K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K210948 | Omnilux CLEAR | Globalmed Technologies | OLP | Class II | |
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | Ezisurg Medical Co., Ltd. | GDW | Class II | |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | KGO | Class I | |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | ArthroCare Corporation | GEI | Class II | |
| K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | EIH | Class II | |
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | PHX | Class II | |
| K202897 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K202551 | Cor-Knot Micro | Lsi Solutions Inc. | GCJ | Class II | |
| K202523 | TMJ Relax | Moonwalker Innovations, Inc. | OCO | Unclassified | |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K201428 | Powder Free Black Nitrile Examination Glove | Vietglove Corporation | LZA | Class I | |
| K211695 | Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | HRS | Class II | |
| K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K211596 | CD Horizon Spinal System | Medtronic, Inc. | OLO | Class II | |
| K211595 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K211408 | CervAlign® Anterior Cervical Plate System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K211045 | Synthetic Vinyl Examination Gloves | Jiangsu Huayuan Medical Technology Co., Ltd. | LYZ | Class I | |
| K210258 | NovoFine | Novo Nordisk a/S | FMI | Class II | |
| K203725 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K203456 | Straumann CARES M-Series CAD/CAM System | Straumann USA, LLC | NHA | Class II | |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | MTD | Class II | |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries SRL | NUV | Class II | |
| K211215 | SenoBright HD | GE Healthcare | MUE | Class II | |
| K210882 | MolecuLight I:X | Moleculight Corp | QJF | Class II | |
| K210881 | M Series Phototherapy Equipment | The Daavlin Distributing Co. | FTC | Class II | |
| K210840 | Disposable Surgical Mask | Safeway Industry Healthcare | FXX | Class II | |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K203720 | Micromate | ISYS Medizintechnik GmbH | JAK | Class II | |
| K203019 | Lf900 | Daesung Maref Co.,Ltd | IRP | Class II |