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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K072500 | One Step Hcg Urine/serum Test | Guangzhou Wondfo Biotech Co., Ltd. | DHA | Class II | |
| K090814 | Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Gyrus ACMI, Inc. | FAJ | Class II | |
| K090732 | Nio Color 3Mp and Mdnc-3121 | Barco N.V. | LLZ | Class II | |
| K090657 | Modification to: S4 Spinal System | Aesculap Inc | NKB | Class II | |
| K090506 | Mayfield Infinity Xr2 Skull Clamp, Model a-2114 | Integra LifeSciences Corporation | HBL | Class II | |
| K090049 | Atlas Implant System- Mini Plus | Cowellmedi Co., Ltd. | DZE | Class II | |
| K090022 | Paradis Vaso Shield | Spinemedica, LLC | OMR | Class II | |
| K083815 | Lanx Fusion System | Lanx, Inc. | MAX | Class II | |
| K083637 | Calix Spinal Implant System | Xtant Medical Holdings, Inc. | ODP | Class II | |
| K090714 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K090679 | Vesselink Microvascular Anastomotic Coupler System | Vioptix, Inc. | MVR | Class II | |
| K090237 | Hg II Fixture System | Hiossen, Inc. | DZE | Class II | |
| K083834 | Terumo Pall Al6x Arterial Filter | Terumo Cardiovascular Systems Corporation | DTM | Class II | |
| K083590 | Iskra Medical Green Irf Prestige | Iskra Medical, d.o.o. | GEI | Class II | |
| K083096 | Latarjet Cortical Screw Set | T.A.G. Medical Products Corporation Ltd | HWC | Class II | |
| K082085 | Capillarys Immunotyping, Model 2100 | Sebia, Inc. | CFF | Class II | |
| K090854 | Abt Glucose Control Solution, Model 2120090 | American Biological Technologies, Inc. | JJX | Class I | |
| K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | MJN | Class II | |
| K090697 | Modification to: Giraffe and Panda Warmer | GE Healthcare | FMT | Class II | |
| K090631 | Pajunk Disposable Balloons and Balloon Systems | Pajunk GmbH Medizintechnologie | GCJ | Class II | |
| K090475 | Validate Cm2 Calibration Verification / Linearity Test Set, Model 402 | Maine Standards Co. | JJY | Class I | |
| K090239 | Progastro Cd Assay | Prodesse, Inc. | LLH | Class I | |
| K090031 | Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model Medaccu2010 | Actherm, Inc. | FLL | Class II | |
| K083799 | Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 | Ark Diagnostics Inc | NWM | Class II | |
| K083659 | Silver Wound Pad | Milliken & Co. | FRO | Unclassified | |
| K083223 | Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01 | Abbott Medical | LFR | Class II | |
| K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | KFM | Class II | |
| K081922 | Autodelfia Neonatal 17A-Oh-Progesterone Kit | Wallac Oy | JLX | Class I | |
| K090999 | Biocardia Morph Sheath Guide | Biocardia, Inc. | DYB | Class II | |
| K090912 | Digital Ultrasonic Diagnostic Imaging System, Model Dp-6900 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | ITX | Class II | |
| K090886 | Rtx 3371 | Tunstall Healthcare | DRG | Class II | |
| K090731 | Novabone Porous - Synthetic Bone Graft Scaffold | Novabone Products, LLC | MQV | Class II | |
| K090702 | Modification to Dash 2500 Patient Monitor | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247 | 3M Company | LBH | Class II | |
| K090278 | Enspire Debrider System | Spine View, Inc. | HRX | Class II | |
| K090218 | Md213mc 21.3 Diagnostic Imaging Lcd Monitor Model, L218tj | Nec Display Solutions, Ltd. | LLZ | Class II | |
| K090215 | Md213mg 21.3 Diagnostic Imaging Lcd Monitor - L218tl | Nec Display Solutions, Ltd. | LLZ | Class II | |
| K090121 | Pre-Filled Catheter Inflation Syringe | Avail Medical Products, Inc. | KNY | Class II | |
| K083910 | Vidistar Pacs & Dicom Viewer Software Server Software System, Heart View, Standalone Viewer | Vidistar, LLC | LLZ | Class II | |
| K083901 | Navi Root | S-Denti Co., Ltd. | LQY | Unclassified | |
| K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone | Astra Tech, Inc. | NHA | Class II | |
| K083787 | Bci Ww1000 Pulse Oximeter, Model Ww1000 | Abbott Medical | DQA | Class II | |
| K083714 | Endoskeleton Tt Interbody Fusion Device (Ibd) | Titan Spine, LLC | MAX | Class II | |
| K083623 | Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100 | Edwards Lifesciences LLC | KRH | Class II | |
| K083381 | Euroimmun Anti-Dsdna-Ncx Elisa (Igg) | Euroimmun US Inc. | LRM | Class II | |
| K083058 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | LHN | Class II | |
| K082997 | Terumo Hybria Closed System Safety i.v. Catheter | Terumo Medical Corp. | FOZ | Class II | |
| K082091 | Tri T-Stat Reagent Assay (Dried Form) Model 25107-00 | Reametrix, Inc. | GKZ | Class II | |
| K072732 | Ortho T. Cruzi Elisa Test System | Ortho-Clinical Diagnostics, Inc. | MIU | Class I | |
| K090618 | Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo C | Cynosure, LLC | GEX | Class II |