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 |
|---|---|---|---|---|---|
| K073228 | Dc Ulnar Shortening System | Orthopro, LLC | HRS | Class II | |
| K073120 | Accin Patellofemoral System | Accelerated Innovation, LLC | KRR | Class II | |
| K073091 | Vidas Nt-Probnp Assay, Model: 30 449 | bioMerieux, Inc. | NBC | Class II | |
| K073061 | The Proxivent Kit | Coll Partners, Ltd. | LBH | Class II | |
| K072802 | Single Use, Disposable, Blue Color, Powder Free Latex Patient Examination Glove | Ultrawin Sdn Bhd | LYY | Class I | |
| K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | JAD | Class II | |
| K072274 | Major III Blood Glucose Monitoring System | Bestgen Biotech Corp. | NBW | Class II | |
| K080219 | Modification To:ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | GZI | Class II | |
| K080145 | Primaeva Medical System | Primaeva Medical, Inc. | GEI | Class II | |
| K080107 | Vitek 2 Gram Negative Piperacillin/tazobactam | bioMerieux, Inc. | LON | Class II | |
| K080068 | Beautifil Opaquer | Shofu Dental Corp. | EBF | Class II | |
| K080032 | Envoycem, Model 1640 | Envoy Medical Corporation | NEA | Class II | |
| K080006 | Affirm with Xpl Handpiece and Er:yag Laser Module | Cynosure, LLC | GEX | Class II | |
| K073557 | EEG Neuroamp, Model Cs10137 | Corscience GmbH & Co. KG | HCC | Class II | |
| K073549 | Q-Plus T | Quanta System Inc. | GEX | Class II | |
| K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Alcon Laboratories | LPL | Class II | |
| K073407 | Pacifica | Or-Nim Medical, Ltd. | MUD | Class II | |
| K073384 | Smart Coupler, Model M015401 | Intelligent Hearing Systems Corp. | GWJ | Class II | |
| K073355 | Calcium, Scal, Nortrol, Abtrol | Thermofisher Scientific Oy | CJY | Class II | |
| K073329 | Sygnal Dbm | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | Class II | |
| K073191 | Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, Abtrol | Thermofisher Scientific Oy | CJE | Class II | |
| K073163 | Limited Artifact Skull Pin, Model 0107 | Dinkler Surgical Devices, Inc. | HBL | Class II | |
| K073116 | Ebi Internal Implant System | Ebi, Inc. | DZE | Class II | |
| K073048 | Peterio Universal Laser Scanning Handpiece | Scilex, Ltd. | GEX | Class II | |
| K073027 | Spectra Mrsa | Thermo Fisher Scientific Oy | JSO | Class II | |
| K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | Intuitive Surgical, Inc. | KCT | Class II | |
| K072054 | Rightest Blood Glucose Monitoring System, Model Gm310 | Bionime Corporation | NBW | Class II | |
| K071343 | Ellman Noble Alloy Electrodes | Ellman International, Inc. | GEI | Class II | |
| K080295 | Charlotte Claw 3.5 | Wrightmedicaltechnologyinc | HRS | Class II | |
| K080247 | Quikclot Nosebleed | Z-Medica, LLC | LYA | Class I | |
| K080242 | Heartway Power Mobility Scooter, Pf7 | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K080147 | Elecsys Probnp II Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K073686 | C.t.m. Power Chair, Model Hs-1500 | C.T.M. Homecare Product, Inc. | ITI | Class II | |
| K073620 | Guardian Hemostasis Valve | Zerusa Limited | DTL | Class II | |
| K073528 | Vena Cava Filter | Cook Incorporated | DTK | Class II | |
| K073369 | Ei Downpak Barrier Sleeves | HU-Friedy Mfg. Co. LLC | EKM | Class I | |
| K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corporation | ESW | Class II | |
| K073150 | Apex-Lnk Poly Acetabular Cup Liners | Omni Life Science, Inc. | LPH | Class II | |
| K073063 | 15W Ceralas D 1470Nm Diode Laser | Biolitec, Inc. | GEX | Class II | |
| K071839 | Soct Copernicus, Model 15205 | Reichert, Inc. | OBO | Class II | |
| K080342 | Nihon Kohden Bedside Monitor, Model Bsm-6000S Series | Nihon Kohden America Inc | MHX | Class II | |
| K080289 | 1500 Pro | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corporation | KGC | Class II | |
| K080206 | Modification to Femostop Femoral Compression System | Radi Medical Systems AB | DXC | Class II | |
| K080144 | Mandrel Guidewires or M-Wires | Lake Region Mfg., Inc. | DQX | Class II | |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | HCG | Class II | |
| K073338 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | NQI | Class II | |
| K073153 | Cardiq Function Xpress | GE Medical Systems SCS | JAK | Class II | |
| K073138 | Cardiq Express Version 2.0 | GE Healthcare | JAK | Class II |