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 |
|---|---|---|---|---|---|
| K011565 | Infant Oxygen Treatment Hood | Gulf Coast Hyperbarics, Inc. | CBF | Class II | |
| K011491 | Helioseal Clear Chroma | Ivoclar North America, Inc. | EBC | Class II | |
| K011069 | Aquasens Fluid Monitoring System | Davol Inc., Sub. C.R. Bard, Inc. | HIG | Class II | |
| K010796 | Aia-Pack Brca, St Aia Pack Brca | Tosoh Medics, Inc. | MOI | Class II | |
| K010547 | Vertex Sealand L/c Orthodontic Sealant | Apex Dental Materials, Inc. | KLE | Class II | |
| K991822 | Allfit Implant System, Short Neck, Model Sti Rt Length, Allfit Implant System, Long Neck, Model Sti Rt Ln Length | Dr. Ihde Dental AG Switzerland | DZE | Class II | |
| K012395 | Mac-Line 02/Co2 Nasal Cannula Sample Line | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K012394 | Oridion Mac-Line Oral Nasal Cannula Sample Line | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K012391 | Mac-Line CO2 Nasal Cannula Sample Line | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K012348 | Maxim Rpg Ps Femoral Component | Zimmer GmbH | JWH | Class II | |
| K012273 | Spiral Radius 90-D Sst System | United States Surgical, A Division of Tyco Healthc | MNH | Class II | |
| K012212 | Modification to Aequalis Shoulder System | TORNIER Inc. | KWS | Class II | |
| K012209 | Capiox Sp Pump with X-Coating Product Code: Cxsp45x | Terumo Cardiovascular Systems Corporation | KFM | Class II | |
| K011803 | Sensititre 18 - 24 Hours Susceptibility Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K011679 | Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility | Embryotech Laboratories, Inc. | POV | Class II | |
| K011603 | Vhs Pediatric Hip Screw System | Walter Abendschein, M.D. | KTT | Class II | |
| K011544 | Hadgel, 4 Gram/syringe | Seikagaku Corp. | LYA | Class I | |
| K011519 | Ameda Hygienikit | Hollister, Inc. | HGY | Class I | |
| K011210 | The Percuquick Set for Percutaneous Dilation Tracheostomy | Rusch Intl. | JOH | Class II | |
| K010754 | Nurse's Assistant o.r. Control System | Valmed SRL | GCJ | Class II | |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013s0431,9013s0441,9013s0451,9013s0461,1013s0421,103s0431 | Medtronic Functional Diagnostics A/S | IKT | Class II | |
| K001245 | 3T L. V. Control Valve | 3T Medical Systems Inc. | MJJ | Class II | |
| K012460 | Model 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K012459 | Model 6494 Unipolar Temporary Myocardial Pacing Wire | Medtronic, Inc. | LDF | Class II | |
| K012458 | Model 6492 Unipolar Temporary Atrial Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K012454 | Model 6491 Unipolar Pediatric Temporary Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K012452 | Model 6500 Unipolar Temorary Myocardial Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K012407 | Paceart Tx3 Cardiac Event Recorder | Paceart, Inc. | DXH | Class II | |
| K012353 | Hnc-127 Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K012289 | Modification to: Viewgt Electronic Portal Imaging Device (Epid) | Elekta Oncology Systems, Ltd. | IYE | Class II | |
| K012187 | Cg-3250 Minireceiver | Card Guard Scientific Survival, Ltd. | DXH | Class II | |
| K011992 | Fhc Microtargeting Drive System | FHC, Inc. | HAW | Class II | |
| K011798 | Corerestore 2 | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K011721 | Esteem Sterile Polyisoprene Surgical Gloves | Medtronic, Inc. | KGO | Class I | |
| K011717 | Sunmax Blue Nitrile Powdered Examination Gloves | Sunmax Enterprise Shanghai Co., Ltd. | LZA | Class I | |
| K011608 | Model 235Ge-64; Multi Purpose Flex Array Coil | Medical Advances, Inc. | MOS | Class II | |
| K011551 | Sure Check Pregnancy Test | Chembio Diagnostic Systems, Inc. | LCX | Class II | |
| K011550 | Hcg Stat Pak Ultra-Fast | Chembio Diagnostic Systems, Inc. | JHI | Class II | |
| K011504 | Baumer Locking Nail | Baumer S.A. | JDS | Class II | |
| K010399 | Diatek Cannon-Cath #Cc2400, Cc2800, Cc3200, Cc3600,cc5500. Cc2400pc, Cc2800pc, Cc3200pc(32 Cm), Cc3200pc(36 Cm) | Diatek, Inc. | MSD | Class II | |
| K010118 | Normed Mandibular Fixation System | Osteomedics, Inc. | JEY | Class II | |
| K012213 | Gulliver and Classe a | American Dental Technologies, Inc. | EIA | Class I | |
| K011906 | Back-Up Meier Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K011878 | Emit (R) Tox Salicylic Assay, Model 7So19ul, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109ul | Syva Co. | DKJ | Class II | |
| K011514 | Instruments for One Time Use - Disposable | Kencap Ltd. | KDD | Class I | |
| K011184 | Intrastent Doublestrut Paramount Xs Biliary Endoprosthesis | Intratherapeutics, Inc. | FGE | Class II | |
| K010852 | Osmed Tissue Expander | Iop, Inc. | NFM | Class II | |
| K010242 | Cook Zilver Biliary Stent | Cook Inc. | FGE | Class II | |
| K012389 | Revolution Xr/d Digital Radiographic Imaging System | GE Healthcare | KPR | Class II | |
| K012385 | Hispeed x/i Smart Gantry Option | GE Healthcare | JAK | Class II |