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 |
|---|---|---|---|---|---|
| K051383 | The Incourage System | Respiratory Technologies, Incorporated | BYI | Class II | |
| K051379 | Protege Rx Gps Self-Expanding Nitrinol Stent | Medtronic, Inc. | FGE | Class II | |
| K051318 | Powder Free Nitrile Examination Gloves (White, Blue, and Purple Color) | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | |
| K051306 | Hoffmann II MRI External Fixation System | Howmedica Osteonics Corp | LXT | Class II | |
| K051292 | Elecsys Rbc Folate Hemolyzed Reagent | Roche Diagnostics GmbH | CGN | Class II | |
| K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | MNH | Class II | |
| K051245 | Polyform Synthetic Mesh | Proxy Biomedical Ltd. | OTO | Class II | |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1 | Implex Corp. | MQP | Class II | |
| K050864 | Parallax Acrylic Resin with Tracers Ta | ArthroCare Corporation | NDN | Class II | |
| K050847 | If True Sine Interferential Stimulator, Model Wl-2206A | Theratech, Inc. | IPF | Class II | |
| K050696 | Medlite C1 Q-Switched Nd:yag Laser | Hoya Photonics, Inc. | GEX | Class II | |
| K050456 | Medrad Avanta Fluid Management Injection System | Medrad, Inc. | DXT | Class II | |
| K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | PAG | Class II | |
| K050156 | Whs-1000 Wound Healing System | Iyia Technologies, Inc. | KPJ | Class II | |
| K043176 | Arc Surgical Resorbable Compression Screw System | Arc Surgical, LLC | HWC | Class II | |
| K041382 | Polygraft Bgs; Bone Graft Substitute | Osteobiologics, Inc. | JDK | Class II | |
| K051504 | Spyscope Access and Delivery Catheter | Boston Scientific Corporation | FED | Class II | |
| K051449 | Ge Vivid 7 with or without Suffix | GE Healthcare | IYN | Class II | |
| K051416 | Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube and Inner Cannula | Mallinckrodt Medical | JOH | Class II | |
| K051414 | Eye Cup, Sterile 1 and Non Sterile | Tollot Pty.Ltd.(Aaxis Pacific) | LXQ | Unclassified | |
| K051361 | Easy Core Detachable Biopsy System | Boston Scientific Corporation | KNW | Class II | |
| K051247 | Sonotip II Ultrasound Needle System | Medi-Globe GmbH | FCG | Class II | |
| K051007 | Accu02 System | Miti Corp. | NFB | Class II | |
| K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | FAS | Class II | |
| K042686 | Energex | Energex Systems, Inc. | NHH | Class II | |
| K051460 | C.cam-Ac | Danish Diagnostic Development A/S | KPS | Class II | |
| K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | HRX | Class II | |
| K051325 | Webpax, Model 200 | Heart Imaging Technologies, LLC | LLZ | Class II | |
| K051319 | Lysus Infusion System | Ekos Corp. | QEY | Class II | |
| K051315 | Modification to: Sectra Ids5 Workstation | Sectra-Imtec AB | LLZ | Class II | |
| K051267 | Gore Resolut Regenerative Material, Gore Resolut Xt Regenerative Membrane, Gore Osseoquest Regenerative Membrane | W. L. Gore & Associates, Inc. | NPK | Class II | |
| K051109 | Bd Phoenix Automated Microbiology System - Erythromycin (Strep) 0.0156 - 4Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051008 | Set | Southern Dental Industries, Inc. | EMA | Class II | |
| K050998 | Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, Ap-a-6063 | Confluent Surgical,Inc | FMF | Class II | |
| K050931 | 6 Fr Dl Powerpicc Catheter | C.R. Bard Inc | LJS | Class II | |
| K050759 | BIPAP Auto | Respironics, Inc. | BZD | Class II | |
| K050523 | Diadexus Plac Test | Diadexus, Inc. | NOE | Class II | |
| K050478 | Medicon Imf-Orion Screws | Medicon, E.G. | DZE | Class II | |
| K050374 | Advia Ims Lithium Assay | Medrad, Inc. | NDW | Class II | |
| K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | ILY | Class II | |
| K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | FRO | Unclassified | |
| K051293 | Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System | Ceremed, Inc. | JEY | Class II | |
| K051246 | Construx Mini Peek Vbr System | Blackstone Medical, Inc. | MQP | Class II | |
| K051220 | Reprocessed Deflectable Electrophysiology Diagnostic Catheters | Sterilmed Inc | NLH | Class II | |
| K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co. | LYZ | Class I | |
| K050965 | Trans1 Axialif System | Trans1 Incorporated | KWQ | Class II | |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models An4320, An4320p, An4321p, An4322p & An3423p | Analogic Corp. | DSI | Class II | |
| K050809 | Cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | KWP | Class II | |
| K050428 | Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars) | Advanced Spinal Technologies, Inc. | LXM | Unclassified | |
| K050208 | Friadent Estheticap | Dentsply International, Inc. | NHA | Class II |