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 |
|---|---|---|---|---|---|
| K001146 | Genyx Flexible Injection Neeedle | Geny Medical, Inc. | FBK | Class II | |
| K001103 | Wireless Ambulatory EEG, Model Ex-Amb-Wireless (Proposed) | Excel Tech., Ltd. | GWQ | Class II | |
| K001101 | Xltek Evoked Potential Headbox, Model Ep-4 | Excel Tech., Ltd. | GWF | Class II | |
| K001095 | Oxygen Sensors, Models Cir, C2r, R13, R15, Ri7med, R22med, R23, R24med, R29med, T1, T2,t4, T7 & Ufo130 | Teledyne Analytical Instruments | CCL | Class II | |
| K001081 | Bioz.pc Hemodynamic Monitor Model Bz-500/Bz-501; Bioz.pc User Software Installation Kit Model Bz-810 | Cardiodynamics International Corp. | DSB | Class II | |
| K001069 | Model 4000 EEG Monitor with Psi (Psa4000) | Physiometrix, Inc. | OLW | Class II | |
| K001059 | Normocarb Sterile Bicarbonate Renal Dialysis | Novex Pharma | KPO | Class II | |
| K000952 | Health-Plus, Sanitex, Reliance Pre-Powdered Latex Examination Gloves - Blue Color | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K000860 | Futura Safety Syringe | Sheila W. Pickering | MEG | Class II | |
| K993939 | Nicolet Eme Legend Tc22 | Nicolet Biomedical, Inc. | IYN | Class II | |
| K993154 | Laser Photolysis System, Pharo Ophthalmic Surgery System | A.R.C. Laser GmbH | GEX | Class II | |
| K992757 | Cynosure Apogee-Tks Dermatological Laser | Cynosure, LLC | GEX | Class II | |
| K001705 | Statsign Electrode Conductivity Gel, Graham-Field Electrode Conductivity Gel, Models 004008, 48-4000 2Gf, 48-4000Gf | Chester Labs, Inc. | GYB | Class II | |
| K001443 | Sugar Chex One | Streck Laboratories, Inc. | JJX | Class I | |
| K001417 | Ontrak Testcup 502, Model 3016641 | Roche Diagnostics GmbH | DKZ | Class II | |
| K001227 | Ultra Vue 55/P & C (Methafilcon a) Soft (Multifocal, Spherical, & Toric) Daily Wear Contact Lens (Clear & Blue Visibilit | Opti-Centre Laboratories | LPL | Class II | |
| K001150 | Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter, Model 60-6 Nee | Novasys Medical, Inc. | GEI | Class II | |
| K001080 | Spine System Evolution | Aesculap Inc | KWP | Class II | |
| K001031 | Uranus, Comfortouch Laser System | Laser Max Medical Technologies Corp. | GEX | Class II | |
| K994419 | Fastpack Psa Immunoassay, Fastpack System | Qualisys Diagnostics, Inc. | LTJ | Class II | |
| K001846 | Elecsys Insulin Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K001700 | Xplan 2.1 | Radionics, Inc. | MUJ | Class II | |
| K001679 | Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | CIT | Class II | |
| K001364 | Bd Directigen Flu A+b | BD Becton Dickinson Vacutainer Systems Preanalytic | PSZ | Class II | |
| K001517 | Shimadzu Mobile X-Ray System Mux-100 Series | Shimadzu Corp. | IZL | Class II | |
| K001382 | Aaron 2100 High Frequency Electrosurgical Generator | Apyx Medical Corporation | GEI | Class II | |
| K001305 | Mac-Lab System and Cardiolab Ep System | General Electric Medical Systems Information Techn | DQK | Class II | |
| K001258 | Bx Transhepatic Biliary Stent and Delivery System | Cordis US Corp. | FGE | Class II | |
| K001180 | Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528 | Pace Medical | DTE | Class II | |
| K001157 | Monarch II IOL Delivery System | Alcon Laboratories | KYB | Class I | |
| K001151 | Electrosurgical Electrode Family | Novasys Medical, Inc. | GEI | Class II | |
| K000707 | Leica Colposcope | Leica Microscopy Systems, Ltd. | HEX | Class II | |
| K000683 | Modified Single Axle Total Elbow | Zimmer GmbH | JDC | Class II | |
| K000619 | Scandinavian Ivf Sciences Ab, G2.2 | Vitrolife AB/Scandinavian Ivf Sciences AB | MQL | Class II | |
| K000565 | Modification to Nc-Stat | Neurometrix, Inc. | JXE | Class II | |
| K001569 | Infinity Amylase Reagent (Procedure No. 580/568) | Sigma Diagnostics, Inc. | JFJ | Class II | |
| K001344 | Advia Ims | Bayer Corp. | DIH | Class I | |
| K001226 | Smith + Nephew RF Arthroscopic Wand System | Smith & Nephew, Inc. | HRX | Class II | |
| K000992 | Macroporedx Distractor System | Macropore Biosurgery, Inc. | MQN | Class II | |
| K994238 | Il Test Liquid Antithrombin | Instrumentation Laboratory Co. | JBQ | Class II | |
| K994139 | First Check Home Drug Test Panel 2 | Worldwide Medical Corp. | LDJ | Class II | |
| K994138 | First Check Home Drug Test Panel 3 | Worldwide Medical Corp. | LDJ | Class II | |
| K993663 | First Check Home Drug Test (Thc) | Worldwide Medical Corp. | LDJ | Class II | |
| K993623 | Gemini E | Allen Medical Instruments Corp. | DQD | Class II | |
| K001686 | Galileo Ventilator | Hamilton Medical AG | CBK | Class II | |
| K001672 | Powder-Free Polymer-Coated Latex Examination Gloves | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K001667 | Resolve Surgical o.r. Towels | Medtronic, Inc. | KKX | Class II | |
| K001649 | Steritec Autoclave Tapes, Model Ci122 & Ci1234 | Steritec Products, Inc. | JOJ | Class II | |
| K001643 | Varis 1.4G | Varian Medical Systems, Inc. | IYE | Class II | |
| K001640 | Biosoft Resin | Biosoft International Corp. | EBI | Class II |