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 |
|---|---|---|---|---|---|
| K014032 | Olympus Ldl Cholesterol Reagent, Olympus Ldl Cholesterol Calibrator, Olympus Hdl/ldl Cholesterol Control Sera | OLYMPUS Corporation of the Americas | LBS | Class I | |
| K014028 | Careside Aptt | Careside Hemotology, Inc. | GFO | Class II | |
| K014015 | Olympus Hdl Cholesterol Reagent; Olympus Hdl Cholesterol Calibrator; Olympus Hdl/ldl Cholesterol Control Sera | OLYMPUS Corporation of the Americas | LBS | Class I | |
| K013864 | Modification to Epi-Star Surgical Laser System, M0del Ds-60 | Nidek, Inc. | GEX | Class II | |
| K013806 | Synthes Metallic Spiked Washers | Synthes (USA) Products LLC | HTN | Class II | |
| K013785 | Urovysion Bladder Cancer Recurrence Kit | Vysis | MMW | Class II | |
| K013755 | Concert Radiopaque Bone Cement | Immedica, Inc. | LOD | Class II | |
| K013307 | Omegatrac, Model Z105 | Teftec Corp. | ITI | Class II | |
| K012938 | Smith & Nephew Image Guided Surgical Instruments for Knee Applications | Smith & Nephew, Inc. | HAW | Class II | |
| K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | MSD | Class II | |
| K020107 | Smartepil | Cynosure, LLC | GEX | Class II | |
| K014144 | Extoral/tescera Glazing Resin, Model T-1804 | Afp Imaging Corp. | EBF | Class II | |
| K014063 | Task Force Monitor 3040 | CNSYSTEMS MEDIZINTECHNIK GmbH | DSB | Class II | |
| K013929 | Heliomolar Hb Translucent Shades | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K013889 | Endoscopic Multi-Fire Clip Applier | Inscope, LLC | PKL | Class II | |
| K013809 | D.sign 59 | Ivoclar Vivadent, Inc. | EJS | Class II | |
| K013778 | Peace of Mind Home Drug Test | Advantage Diagnostics Corp. | MVO | Unclassified | |
| K013732 | Gelzone | Implantech Associates Inc | MDA | Class I | |
| K012589 | Fast Set Putty | Synthes (USA) Products LLC | GXP | Class II | |
| K002604 | Centurion 2000 Central Station Arrhythmia Patient Monitoring System | Invivo Research, Inc. | DSI | Class II | |
| K020263 | Logiq 3 | General Electric Co. | IYN | Class II | |
| K020249 | Microscan Plus Gram Negative Mic/combo Panels with Meropenem (0.12-32 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020246 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Imipenem (0.25, 1-32 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020229 | R & D Body Fluid Control | R & D Systems, Inc. | JPK | Class II | |
| K020209 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Amikacin (0.25-128 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020185 | Microscan Rapid/s Plus Gram-Negative Mic Combo Panels with Gentamicin (0.12-32 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020182 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Netilmicin (0.12-32 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020173 | Microscan Synergies Plus Gram Negative Mic/combo Panels with Tetracycline (0.12-128 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020168 | Microscan Synergis Plus Gram Negative Mic/combo Panels with Tobramycin (0.12-32 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K020109 | Sigma Diagnostics Accuclot La Control | Sigma Diagnostics, Inc. | GGC | Class II | |
| K020084 | Fukuda Denshi Dynascope Model Ds-5700 | Fukuda Denshi USA, Inc. | DSI | Class II | |
| K020048 | Modification to Geo Structure | Interpore Cross Intl. | MQP | Class II | |
| K014187 | Autovac Orthopedic Autotransfusion System | Boehringer Laboratories, LLC | CAC | Class II | |
| K014169 | Water Purification Components for Hemodialysis | Bob J. Johnson & Assoc., Inc. | FIP | Class II | |
| K013914 | Powderfree Latex Surgeon's Gloves | Kanam Latex Industries Pvt. Ltd. | KGO | Class I | |
| K013854 | Mark 5000 Quadrature Shoulder Coil | GE Healthcare Coils | MOS | Class II | |
| K013781 | Rididfix 2.7Mm Btb Cross Pin Kit | Mitek Products | HTY | Class II | |
| K013751 | Handheld Gamma Finder (Hgf) | Silicon Instruments Gmhb | IZD | Class I | |
| K013730 | Ariel Radio Frequency (RF) Electrosurgical Control Module and Accessories | Novasys Medical, Inc. | GEI | Class II | |
| K013723 | Modification to: Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | ITX | Class II | |
| K013717 | Brentwood Real Time St and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | DPS | Class II | |
| K013006 | Ovus Capless Safety Needle | Ovus Systems | MEG | Class II | |
| K012621 | Clearmedical/hentleigh Deep Vein Thrombosis (Dvt) Garment | Clearmedical, Inc. | JOW | Class II | |
| K012616 | Clearmedical/huntleigh Foot Garments; Models Fg200/lrg (Large), Fg200/std (Standard), Fg100/sm (Small), Fg100-R (Regular | Clearmedical, Inc. | JOW | Class II | |
| K012612 | Clearmedical/novamedix Avi Foot Cover, Pair, Regular & Large Size | Clearmedical, Inc. | JOW | Class II | |
| K012606 | Clearmedical/kendall Knee-High Scd Sleeves, Clearmedical/kendall Thigh-High Scd Sleeves, Medium,small, Large | Clearmedical, Inc. | JOW | Class II | |
| K012601 | Clearmedical/aircast Venaflow Calf Cuff, Clearmedical Aircast Xl Venaflow Calf Cuff, Clearmedical/aircast Venaflow Thigh | Clearmedical, Inc. | JOW | Class II | |
| K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | LLZ | Class II | |
| K011540 | Viewpoint Central Monitoring System, Model 0998-00-0187-07 | Datascope Corp. | MHX | Class II | |
| K010175 | Microlight 830 Laser System | Microlight Corporation of America | NHN | Class II |