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 |
|---|---|---|---|---|---|
| K062984 | Medline Hypodermic Needles | MEDLINE INDUSTRIES, LP - Northfield | FMI | Class II | |
| K062920 | Orthofix Titanium Humeral Plating System Lsp | Orthofix SRL | KTW | Class II | |
| K062908 | Orthropro Hemi Toe | Orthopro, LLC | KWD | Class II | |
| K062898 | Sbi Lateral Rhead Implant | Small Bone Innovations, Inc. | KWI | Class II | |
| K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | NBW | Class II | |
| K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | DKZ | Class II | |
| K061696 | Iqqa-Liver Software | Edda Technology, Inc. | LLZ | Class II | |
| K060544 | Salto Talaris Total Ankle Prosthesis | TORNIER Inc. | HSN | Class II | |
| K063267 | Isite Pacs, V 4. X | Stentor Inc., A Philips Medical Systems Co. | LLZ | Class II | |
| K063266 | 3Mp Medical Monochrome Reference Display, Model Mdm2130-3Nc | Chi Lin Technology Co., Ltd. | LLZ | Class II | |
| K063241 | Cstc-002A, Extended Field of View Software Option | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K063207 | S-Scan MRI System | Esaote S.p.A. | LNH | Class II | |
| K063120 | Color Lcd Monitor, Radiforce, Model Rx210 | Eizo Nanao Corporation | LLZ | Class II | |
| K063102 | Microscan Microstrep Plus Panel Cefaclor (0.5 - 8 Mcg/ml) | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K063081 | Aequalis Shoulder System | TORNIER Inc. | HSD | Class II | |
| K062955 | Powder Free Latex Examination Gloves, Small, Medium, Large, X-Large | Pt. Haloni Jane | LYY | Class I | |
| K062884 | Powder-Free Vinyl Patient Examination Gloves, Clear(non-Colored) | Suqian Green Glove Co., Ltd. | LYZ | Class I | |
| K062839 | Modification to Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K062782 | Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001 | Inion Oy | MAI | Class II | |
| K062733 | Tomas Pin Sd 6, 8, and 10 Mm | Dentaurum Inc. | OAT | Class II | |
| K062723 | Halo90 Coagulation Catheter | Barrx Medical, Incorporated | GEI | Class II | |
| K062605 | Philips Spo2 Reusable Sensor, Models M1196a and M1196t | Philips North America LLC | DQA | Class II | |
| K062474 | Smithwick Carotid Shunt | Mcpherson Enterprises, Inc. | DXC | Class II | |
| K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | Isoray, Inc. | KXK | Class II | |
| K062241 | Adjustable Multi-Catheter Source Applictor | North American Scientific, Inc. | JAQ | Class II | |
| K062186 | Asahi Ptca Guide Wire, Fielder J, Model Agp140000j, Agp140300j | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K062155 | Digital Mxr-D Flowmeter | Precision Fluidics Division Parker Hannifin Corp. | BSZ | Class II | |
| K062109 | Binaxnow Influenza a & B Test | Binax, Inc. | PSZ | Class II | |
| K062064 | Riva Bond Lc | Southern Dental Industries, Inc. | EMA | Class II | |
| K061653 | Soyala Full Face Mask | Weinmann Gerate Fur Medizin GmbH + Co. KG | BZD | Class II | |
| K060907 | Karl Storz Video Gastroscopes | Karl Storz Endoscopy-America, Inc. | FDS | Class II | |
| K062930 | Ladarwave Customcornea Wavefront System | Alcon Laboratories | NCF | Class I | |
| K062409 | K-Etchant Gel | Kuraray Medical, Inc. | EBF | Class II | |
| K062369 | Iridex Oculight Tx | Iridex Corporation | GEX | Class II | |
| K062228 | Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless Instrumentation | Zimmer GmbH | HAW | Class II | |
| K062127 | Medic4all Telemedicine System, Model Vms-01 (Nibp) | Medic4all (Israel), Ltd. | DRG | Class II | |
| K061935 | Sensacare Saw-102 Wrist Digital Blood Pressure Monitor | Sensacare, Ltd. | DXN | Class II | |
| K061905 | Horizon Cardiology ECG-Mckesson's ECG Management System, Model 1.0 | Medcon, Ltd. | DQK | Class II | |
| K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy Vu1 | Hypermed, Inc. | MUD | Class II | |
| K063093 | Sectra Workstation, Version 11.1 | Sectra-Imtec AB | LLZ | Class II | |
| K063079 | I-Stop Trans Obturator Male Sling | CL MEDICAL Inc. | OTM | Class II | |
| K062757 | Xeron Pacs | Xeron Healthcare Corp. | LLZ | Class II | |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091 | Hologic, Inc. | LSL | Class II | |
| K062422 | Humeral Head, Manual Driver | Teleflex Medical | FMI | Class II | |
| K062135 | Art Shielded Breast Applicator | Advanced Radiation Therapy, LLC | JAQ | Class II | |
| K062043 | Body Composition Monitor with Scale, Model Hbf-500 | Omron Healthcare Co., Ltd. | MNW | Class II | |
| K052742 | Hepasphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | |
| K052599 | 66 Vision Tech Ophthalmoscope, Models Yz6e, Yz6f, Yz6g, Yz11, Yz11c, Yz11d, Yz25a | Suzhou 66 Vision Tech Co., Ltd. | HLJ | Class II | |
| K063083 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II |