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 |
|---|---|---|---|---|---|
| K062946 | Top Neuropole Needles, Models St, X, Rc, Xe and Tl | Top Corp. | GXI | Class II | |
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Inc. | MNW | Class II | |
| K061467 | Exsept Wc Wound Cleanser | Alcavis International, Inc. | FRO | Unclassified | |
| K070101 | Uniblate Electrosurgical Device | Boston Scientific Corporation | GEI | Class II | |
| K063824 | Bd Phoenix Automated Microbiology System - Aztreonam (Gn) 0.5-64Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K063697 | Special Sprotte, Chiba, Dr Steinhoff Kit | Pajunk GmbH Medizintechnologie | KNW | Class II | |
| K063544 | Modification to Pyrenees Cervical Plate System | K2M, Inc | KWQ | Class II | |
| K062569 | Safeguard 24 Cm Pressure Assisted Dressing | Datascope Corp. | DXC | Class II | |
| K062546 | Immunocard Stat! Ehec, Model 751630 | Meridian Bioscience Inc | GMZ | Class I | |
| K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | NHA | Class II | |
| K061897 | Excel Contra Angle Handpiece | Orthosource, Inc. | EGS | Class I | |
| K070187 | Powder Free Vinyl Patient Examination Glove | Hong di Plastic Products Co., Ltd. | LYZ | Class I | |
| K063860 | Thrombigel Thrombin/gelatin Foam Hemostat | Vascular Solutions LLC | QSX | Unclassified | |
| K063203 | Electric Wheelchair, Model Rumba S (Hp4) | Imc-Heart Way LLC | ITI | Class II | |
| K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube | C.R. Bard Inc | KNT | Class II | |
| K062739 | Cinch Bone Anchor System | Sapphire Medical, Inc. | MBI | Class II | |
| K062200 | Collagen Matrix Anorganic Bone Mineral Bone Graft Materials | Collagen Matrix, Inc | MQV | Class II | |
| K052836 | Bodihealth System | USA Laser Therapeutics, Inc. | GZJ | Class II | |
| K070287 | Ps Series with Fiber Light Guide and Headlight, Models Ps200, Ps250, Ps500 | Photonic Optische Gerate GmbH & Cokg | EBA | Class I | |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | LYC | Class II | |
| K063441 | 15.5Fr Alta Gold, Coated Hemodialysis Catheter, Model Alc19sh24, Alc23sh28, Alc27sh32, Alc31sh36, Alc35sh40, Alc50sh55 | Spire Biomedical, Inc. | MSD | Class II | |
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement Device | Medisystems Corp. | FIE | Class II | |
| K061252 | Pre-Cemented Orthodontic Bracket System | Primus Consulting | DYH | Class II | |
| K070244 | Aegis | Sentinelle Medical, Inc. | LLZ | Class II | |
| K070094 | Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System | Varian Medical Systems, Inc. | IYE | Class II | |
| K070075 | Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | |
| K063811 | Bd Phoenix Automated Microbiology System - Cefazolin (Gn) 0.5-32Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | GAT | Class II | |
| K063682 | Intralase Fusion Laser | Intra Lase Corp. | GEX | Class II | |
| K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | EBF | Class II | |
| K063571 | Palomar Lux2940 Handpiece | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K063477 | Novamed MRI Conditional Laryngoscope Set | Novamed Co., Ltd. | CCW | Class I | |
| K063386 | Lorenz Orthodontic Anchorage System | Biomet Microfixation | OAT | Class II | |
| K063114 | Disposable Transfer Sets with and without Swabbable Valves And/or Check Valves | Coeur, Inc. | FPK | Class II | |
| K063026 | Ok Meter Blood Glucose Monitoring System | OK Biotech Co., Ltd. | NBW | Class II | |
| K062532 | Electropulse - Low Back Pain | Pain Relief Technologies | NUH | Class II | |
| K062012 | S4 Cervical Occipital Plate Spinal System | Aesculap Inc | NKB | Class II | |
| K070241 | Modification to Lapidus Plate | New Deal, S.A. | HRS | Class II | |
| K070160 | Modification to Ttc Plates | New Deal, S.A. | HRS | Class II | |
| K070122 | Monochrome Lcd Monitor, Model Radiforce Gx320 | Eizo Nanao Corporation | LLZ | Class II | |
| K070043 | Powder Free Vinyl Patient Examination Gloves, White | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K070028 | Classic/hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer | Actherm, Inc. | FLL | Class II | |
| K070008 | Powdered Vinyl Patient Examination Gloves | Zibo Hengde Plastic & Rubber Products Co., Ltd. | LYZ | Class I | |
| K063839 | Positioner | C-Rad Positioning AB | IYE | Class II | |
| K063820 | Lisfranc Plate | New Deal, S.A. | HRS | Class II | |
| K063725 | Mp5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | MHX | Class II | |
| K063700 | Spyglass Irrigation System | Medical Scientific, Inc. | LJH | Class II | |
| K063683 | Olympus Xeu-M60a Endoscopic Ultrasound Center; Xgf-Um180 Ultrasonic Gastrovideoscope | Olympus Medical Systems Corp. | IYN | Class II | |
| K063626 | Duraflex | Cosmetic Dental Materials, Inc. | EBI | Class II | |
| K063624 | Kavo Everest C-Temp | Kavo America | EBG | Class II |