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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K222340 | Chartis Precision Catheter | PULMONX, Corp. | CBI | Class II | |
| K222297 | CentriMag Pre-connected Pack | Abbott Medical | DTZ | Class II | |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | EZL | Class II | |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | LHN | Class II | |
| K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | LZA | Class I | |
| K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd. | DQK | Class II | |
| K213768 | Bolt Navigation System | Circinus Medical Technology, LLC | OWB | Class II | |
| K223328 | Purgo | Aeroclean Technologies, Inc. | FRA | Class II | |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co. Ltd. | QRL | Class II | |
| K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | |
| K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | JKA | Class II | |
| K222044 | Elos Accurate Customized Abutment | Elos MedTech Pinol a/S | NHA | Class II | |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Medtronic, Inc. | GDW | Class II | |
| K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl | Rhino Health, Inc. | LZA | Class I | |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft Ltd | OLT | Class II | |
| K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | FYC | Class II | |
| K222641 | Signia™ Small Diameter Reloads Including Regular (Round) Tip Version | Medtronic, Inc. | GDW | Class II | |
| K222408 | Disposable Safety Lancet | Beijing Ruicheng Medical Supplies Co., Ltd. | FMK | Class II | |
| K213943 | SmartSurgN Visualization System | Smartsurgn Incorporated | OWN | Class II | |
| K213917 | QStat Cartridge | Hemosonics, LLC | QFR | Class II | |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | ulrich medical USA Inc | NKB | Class II | |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC. | QRL | Class II | |
| K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical, Inc. | GEI | Class II | |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | Cardicare Company, Ltd. | DXQ | Class II | |
| K222611 | Male Latex Condoms | Suzhou Colour-way New Material Co., Ltd. | HIS | Class II | |
| K222363 | Aevumed PHANTOM™-LP Suture Anchors | Aevumed, Inc. | MBI | Class II | |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | |
| K221279 | pNOVUS 21 Microcatheter | Phenox Inc | DQO | Class II | |
| K220630 | TorchTM Software | Voximetry, Incorporated | LLZ | Class II | |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | JKH Health Co., Ltd. | FLL | Class II | |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | MQB | Class II | |
| K222918 | DentCare Aligners | Dentcare Dental Lab Pvt. Ltd. | NXC | Class II | |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci.&tech.co.,Ltd. | LYY | Class I | |
| K213215 | VSI HoloMedicine | Apoqlar GmbH | LLZ | Class II | |
| K223292 | TempSure System | Cynosure, LLC | GEI | Class II | |
| K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) | Guangdong Golden Leaves Technology Development Co., Ltd. | FXX | Class II | |
| K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | Avanti Orthopaedics LLC | HWC | Class II | |
| K222656 | LDE4 Lancing Device | I-SENS, Inc. | QRL | Class II | |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd | EHD | Class II | |
| K222534 | Nitrile Patient Examination Glove | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | LZA | Class I | |
| K222463 | EchoGo Heart Failure | Ultromics, Ltd. | QUO | Class II | |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co., Ltd. | MEG | Class II | |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | Baisheng Medical Co.,Ltd. | GEI | Class II | |
| K221210 | PainShield MD PLUS | Nanovibronix, Ltd. | PFW | Class II | |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | EBZ | Class II | |
| K213459 | Glenoid Reconstruction System | Medacta International SA | PHX | Class II | |
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | ONB | Class II | |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | GE Medical Systems SCS | LLZ | Class II | |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | NAY | Class II |