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 |
|---|---|---|---|---|---|
| K003075 | Knightstar 330 Ventilator | Mallinckrodt, Inc. | MNT | Class II | |
| K013804 | Socrates Robotic Telemonitoring System | Computer Motion, Inc. | NEQ | Class II | |
| K013753 | Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color | Canopus Medical Supply Co., Ltd. | LYZ | Class I | |
| K013708 | Reference Check, Catalog Number-Rcn-10 | Precision BioLogic Inc. | GIZ | Class II | |
| K013400 | Synergy Flow | Coltene /Whaledent AG | EBF | Class II | |
| K013060 | Ics Medical Model Vg-30 Video Goggles | Ics Medical Corp. | GWN | Class II | |
| K013050 | The Bioplate Zip Craniotomy Fixation System | Bioplate Inc | GXN | Class II | |
| K012588 | Oxoid Pylori Test Kit, Model Dr0130m | Oxoid, Ltd. | LYR | Class I | |
| K011849 | Micro-6-Series (Mr-6, Mr-6L) Ureteroscopes, Mro-6 Series (Mr-633, Mr-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros | Circon Video | FGB | Class II | |
| K011683 | Nurvo 9000 Endocavitary Coils | GE Healthcare Coils | MOS | Class II | |
| K011451 | Reunite Fusion Screw | Zimmer GmbH | HWC | Class II | |
| K011244 | Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System | Zeus Scientific LLC | LKJ | Class II | |
| K001003 | Z-Net | Demite Limited | FMW | Class I | |
| K993535 | Metapak Multi-Purpose Instrument Tray | Riley Medical, Inc. | FRG | Class II | |
| K013880 | Daylite Xenon Light Sources | Designs for Vision, Inc. | GCT | Class II | |
| K013878 | Cybermed, Inc., V-Works | Cybermed Inc. | LLZ | Class II | |
| K013734 | Mas Lipid Control, Liquid Assayed Lipid Control, Level 1 and 2, Dade Lipid Control, Liquid Assayed Lipid Control, Level | Medical Analysis Systems, Inc. | JJY | Class I | |
| K013727 | Sterile Powder Free Latex Surgical Gloves with Protein Claim Less Than 50 Ug/g | Smart Glove Corp. Sdn Bhd | KGO | Class I | |
| K013686 | Kodak Directview Tabletop Cassette | Eastman Kodak Company | IXA | Class II | |
| K013537 | Royal Imperial Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) | Koon Seng Sdn Bhd | LYY | Class I | |
| K013333 | Latex Examination Gloves Powderfree Polymer Coated with Protein Concent Label Claim | Innovative Gloves Co;, Ltd. | LYY | Class I | |
| K013256 | Bi-3M Needle-Free Injector System | Felton International, Inc. | KZE | Class II | |
| K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe | Med Gen, Inc. | FQM | Class I | |
| K013146 | Viatronic V3d Calcium Scoring | Viatronix, Inc. | JAK | Class II | |
| K013098 | Kimax Remote Viewing Station | Medical Metrics, Inc. | LLZ | Class II | |
| K013055 | The Bioplate Bioclip Craniotomy Fixation System | Bioplate Inc | JEY | Class II | |
| K013040 | Light Saber Introducer Needle | Minrad, Inc. | MDM | Class I | |
| K013037 | Excel A.v Fisutal Needle Set | Exelint Intl. Co. | FIE | Class II | |
| K013036 | Nomos Motorized Crane II | Nomos Corp. | JAI | Class II | |
| K013035 | Guardian Limb Salvage System | Wrightmedicaltechnologyinc | KRO | Class II | |
| K013031 | Most Options System | Sulzer Orthopedics, Inc. | KRO | Class II | |
| K012186 | Master & Frank Surgical Gowns (Sterile) | Master & Frank Ent. Co., Ltd. | FYA | Class II | |
| K013861 | Modification to Leksell Surgiplan with Atlaspace | Elekta Instrument AB | HAW | Class II | |
| K013789 | Excelsior Sl-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific Corporation | DQY | Class II | |
| K013761 | Medline Excel Reclincer Wheelchair | MEDLINE INDUSTRIES, LP - Northfield | IOR | Class I | |
| K013683 | Modification to: Abbott Vascular Suture Anastomosis Device | Abbott Vascular | GAW | Class II | |
| K013659 | Modification to Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | MUH | Class II | |
| K013650 | Orthophos Ds/dc Ceph, Orthophos 5/Plus/cd | Sirona Dental Systems GmbH | MUH | Class II | |
| K013412 | At Home Drug Test, Model 9069 | Phamatech Inc. | MVO | Unclassified | |
| K013410 | At Home Drug Test, Model 9064 | Phamatech Inc. | MVO | Unclassified | |
| K013409 | At Home Drug Test, Model 9074 | Phamatech Inc. | MVO | Unclassified | |
| K013408 | At Home Drug Test, Model 9079 | Phamatech Inc. | DJG | Class II | |
| K013407 | At Home Drug Test, Model 9084 | Phamatech Inc. | DJG | Class II | |
| K013047 | Fotona Dualis Nd:yag Laser System, Fotona Twinlight Nd:yag Laser System | Mojca Valijavec | GEX | Class II | |
| K013028 | Palomar Slp 1000 | Palomar Medical Products, Inc. | GEX | Class II | |
| K013027 | Mister Neb Nebulizer Compressor, with Nebulizer, Model Hs123 | Respironics Healthscan, Inc. | BTI | Class II | |
| K013017 | Medigroup Key Tube | Janin Group, Inc. | FJS | Class II | |
| K012631 | Reprocessed Soft Tissue Ablators | Alliance Medical Corp. | GEI | Class II | |
| K012337 | Bayer Advia Ims System; C-Reactive Protein System | Bayer Corp. | DCN | Class II | |
| K011893 | Cosmetica (Polymacon) Soft (Hydrophilic) Contact Lenses | Contact Color SRL | LPL | Class II |