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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K900402 | Add'l Uses for the Kodak Surecell Chlamydia Kit | Eastman Kodak Company | LJC | Class I | |
| K900368 | P2/chemo Plus Gloves | Biosafety Systems, Inc. | LYY | Class I | |
| K900287 | Mrt 50A Cranio-Cervical Coil | Toshiba America Mri, Inc. | LNH | Class II | |
| K900286 | Mrt 50A Spine Surface Coil | Toshiba America Mri, Inc. | LNH | Class II | |
| K900152 | Poly Patient Examination Gloves | Shanghai Strong Plastic Products Co., Ltd. | LYZ | Class I | |
| K900092 | Modified Safe Vinyl Examination Gloves | Universal Gloves Corp. | LYZ | Class I | |
| K900088 | Masks Surgical Dental | Kab Gloves Unltd. | FXX | Class II | |
| K897079 | Accuprobe Haeomphilus Influenzae Culture | Hologic, Inc. | MCC | Class II | |
| K897013 | Avi Micro 210Cm Infusion Pump | 3M Company | FRN | Class II | |
| K896943 | Site Disposable Cutter and Accessories | Site Microsurgical Systems, Inc. | HQE | Class II | |
| K896942 | Spacelabs Model 90480 EEG Module | Spacelabs, Inc. | GWQ | Class II | |
| K896939 | Disposable Fiber Optic Delivery System for Nd:yag | Fiber Delivery Concepts, Inc. | GEX | Class II | |
| K896913 | Spirit | Ormco Corp. | DYW | Class II | |
| K896878 | Handpiece System with Motor (Several Models) | Micro Motors, Inc. | EFB | Class I | |
| K896675 | Sterling Style 90 Surgical Gloves | Steril Rubber Sdn. Bhd. | KGO | Class I | |
| K896673 | Latex Patient Examination Gloves | Alliance Rubber Products Sdn. Bhd. | LYY | Class I | |
| K896672 | Latex Patient Examination Gloves | U.O.P. Rubber Products Sdn Bhd | LYY | Class I | |
| K896527 | Powder-Free Dantex Vinyl Examination Gloves | Dan Co., Ltd. | LYZ | Class I | |
| K896456 | Tct-500S Computed Tomography X-Ray System | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K896190 | Cardiocap(tm) Cmx-104 Monitor | Datex Division Instrumentarium Corp. | DPS | Class II | |
| K895941 | Patient Examination Gloves (Latex) | Gim'S Trading Corp. | LYY | Class I | |
| K895704 | Ati Disp. Biological Test Pack for Ethylene Oxide | Pymah Corp., Ati Div. | FRC | Class II | |
| K895541 | V.i.p. Bird Infant - Pediatric Ventilator | Bird Products Corp. | CBK | Class II | |
| K894478 | Uhmwpe Surgical Mesh | Zimmer GmbH | KKY | Class II | |
| K900413 | Intelect 775Mp Powered Muscle Stimulator | Chattanooga Group, Inc. | IPF | Class II | |
| K900035 | Wilson-Cook Colon Decompression Set | Wilson-Cook Medical Inc. | FEG | Class II | |
| K896952 | Thermoscan-Instant Thermometer Model Ir-2000 | Thermoscan, Inc. | FLL | Class II | |
| K896879 | Oral Surgery Handpiece and Attachments | Micro Motors, Inc. | EFB | Class I | |
| K896877 | Dental Air Motors (Several Models) | Micro Motors, Inc. | EFB | Class I | |
| K896876 | Dynatorq Dental Handpiece Attachments | Micro Motors, Inc. | EFB | Class I | |
| K896448 | Balloon Dilation Catheter | Cook Ob/Gyn | EZN | Class II | |
| K896278 | Sceptor - New Antimicrobial Agent - Cefotetan | BD Becton Dickinson Vacutainer Systems Preanalytic | JWY | Class II | |
| K896061 | Erection Device | Clyde Engineering Service | LKY | Class II | |
| K895988 | Potassium Nitrate-Zinc Oxide Eugenol Temp. Dental | Milton Hodosh, M.D. | EMA | Class II | |
| K895345 | Orad Toothbrush Cleaner | Orad, Inc. | EFT | Class I | |
| K894459 | Angioscope | Intramed Laboratories, Inc. | LYK | Class II | |
| K894250 | Le Pta Catheter | Baxter Healthcare Corporation | LIT | Class II | |
| K893220 | Verimed Myoexorciser Veristim | Verimed Holdings, Inc. | IPF | Class II | |
| K900906 | Factor II Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900875 | Raichem(tm) Spia(tm) Transferrin Reagent | Reagents Applications, Inc. | DDG | Class II | |
| K900655 | Modified Captia(r) Toxo-M | Mercia Diagnostics, Ltd. | LGD | Class II | |
| K900626 | Alpha Urine Sample | Toxi-Lab, Inc. | DIF | Class I | |
| K900605 | 3.2-5Mm Unipolar Lead Upsizing Kit, Model Ak 100 | Possis Medical, Inc. | DTD | Class II | |
| K900462 | Osteonics Cement Restrictor | Osteonics Corp. | JDK | Class II | |
| K900412 | Factor XII Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900411 | Factor XI Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900410 | Factor X Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900409 | Factor IX Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900408 | Factor VIII Deficient Plasma | Sigma Chemical Co. | GJT | Class II | |
| K900407 | Factor VII Deficient Plasma | Sigma Chemical Co. | GJT | Class II |