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 |
|---|---|---|---|---|---|
| K070877 | Endocervical Electrode # 2 | Modern Medical Equipment Mfg., Ltd. | HGI | Class II | |
| K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | NUV | Class II | |
| K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | KGO | Class I | |
| K063355 | D-Line Catheter St, Double Lumen St; Extra Flow | Novosci Corp | MPB | Class II | |
| K063275 | Distal Clavicular Fragment Immobilization Plate Left, Model 1810-116_126-03 (05,07) Right 1811-116_126-03 (05,07) | Terray Corp. | HRS | Class II | |
| K062992 | Spinal Spheres | Interbody Innovations, LLP | NVR | Class III | |
| K071819 | Ncontact Visitrax Guided Coagulation System Kit, Models Csk-212 and Csk-515 | Ncontact Surgical, Inc. | OCL | Class II | |
| K071786 | Portrait Psr | Rhytec Incorporated | GEI | Class II | |
| K071776 | Aneuroplastic, Model 43-1290 | Cerenovus, Inc. | JXH | Class II | |
| K071503 | System, Tomography, Computed Emission | Syntermed, Inc. | KPS | Class II | |
| K071325 | Biomet Variable Locking Plate System | Biomet Trauma | HRS | Class II | |
| K071284 | Model Segaego 3D Scooter | Dalton Medical Corp. | INI | Class II | |
| K071251 | Demi | Sybron Dental Specialties, Inc. | EBZ | Class II | |
| K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate) | Sgmp Co., Ltd. | LYY | Class I | |
| K070766 | Psi Bands | Psi Health Solutions, Inc. | MVV | Unclassified | |
| K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | HTY | Class II | |
| K063495 | C Type, CT Type, and Special Type Orthodontic Anchor Screws | Biomaterials Korea Inc. | OAT | Class II | |
| K061914 | Sport-Elec, Models Duo Ct5 Slimness and Ct5 Slimness | Sport-Elec | NGX | Class II | |
| K071784 | Depuy Pinnacle with Gripton Acetabular Cups | Depuy Orthopaedics Inc. | LPH | Class II | |
| K071583 | Cermet III Acetabular Cup System | Implants International, Ltd. | MEH | Class II | |
| K071364 | Microtargeting Guideline 4000 | FHC, Inc. | GZL | Class II | |
| K071209 | Master Guard Latex Powder Free Examination Gloves | High Momentum Sdn Bhd | LYY | Class I | |
| K071174 | Pathfinder System Polyaxial Pedicle Screws | Spinal Concepts, Inc. | NKB | Class II | |
| K071131 | Uno | 3M Espe AG Dental Products | KLE | Class II | |
| K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories | Prosurg, Inc | JEY | Class II | |
| K070175 | Aquanova Super-Absorbent Gelling Dressing, OTC | Medtrade Products Ltd. | QSY | Unclassified | |
| K063427 | Lumina Intense Pulsed Light (& Laser) System | Lynton Lasers Limited | GEX | Class II | |
| K053613 | L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active | Theo Manufacturing BV | FRO | Unclassified | |
| K071733 | Dl900 Series Holter Recorder | Braemar Manufacturing, LLC | MWJ | Class II | |
| K071119 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, White) | Gx Corporation Sdn Bhd | LZA | Class I | |
| K070784 | Inion Biorestore | Inion Oy | LYC | Class II | |
| K070767 | Eye See Multipurpose Contact Lens Solution | Lapis Lazuli International NV | LPN | Class II | |
| K071847 | Magnetic Resonance Diagnostic Device, Model Cg-Kfc18-H150-Ap - Knee/foot/ankle Coil | Shanghai Chenguang Medical Technologies Co, Ltd | MOS | Class II | |
| K071701 | Trackleaf-10 | Direx Systems Corp. | IYE | Class II | |
| K071602 | Imagic V2.0 | Ashva Technologies, Pvt., Ltd. | LLZ | Class II | |
| K071572 | Capiox Fx05 Hollow Fiber Oxygenator with Integrated Arterial Filter | Terumo Corp. | DTZ | Class II | |
| K071191 | Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit | Novartis Nutrition Corp. | FPD | Class II | |
| K071166 | Uniweb, Version 5.0 | Electronic Business Machine Co., Ltd. (Ebm) | LLZ | Class II | |
| K062703 | One Step Hcg Pregnancy Test | Ai de Diagnostic Co., Ltd. | LCX | Class II | |
| K071801 | Vitros Chemistry Products Ci-Slides, Calibrator Kit 2, Model(s) 844-5207, 166-2659 | Ortho-Clinical Diagnostics, Inc. | JIX | Class II | |
| K071714 | Navitrack System - Os Unicondylar Knee Universal, Model# Pro-06003 | Orthosoft, Inc. | HAW | Class II | |
| K071393 | Jazz Blood Glucose Monitoring System | Agamatrix | NBW | Class II | |
| K071390 | Wheelchair Model Sts | Innovative Products, Inc. | IPL | Class II | |
| K071300 | Modification to Smith & Nephew RF Denervation Probes & RF Cannulae | Smith & Nephew, Inc. | GXI | Class II | |
| K071183 | Allegro Oculyzer | WAVELIGHT GmbH | MXK | Class II | |
| K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | KWT | Class II | |
| K071027 | Triboglide Lubricated Silicone-Free Syringe | Tribofilm Research, Inc. | FMF | Class II | |
| K070966 | Gso Gs1 Spinal System | Gold Standard Orthopaedics, LLC | KWP | Class II | |
| K070882 | Stryker Peek Twinloop Tac | Stryker Corp. | MBI | Class II | |
| K071745 | Baylis Pain Management Single-Use Probe | Baylis Medical Co., Inc. | GXI | Class II |