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 |
|---|---|---|---|---|---|
| K082246 | Dignity 100 | Dignity Medical Devices, Inc. | IOR | Class I | |
| K082146 | Metha Short Stem Hip System Xl Femoral Head | Aesculap Inc | LWJ | Class II | |
| K081919 | Uf-870 Ag Diagnostic Ultrasound System | Fukuda Denshi Co., Ltd. | ITX | Class II | |
| K081744 | Pascal Synthesis Delivery System | OptiMedica Corp. | GEX | Class II | |
| K081659 | Rainbow Adhesive Co-Oximetry Sensor, Models Ri-25-L, Ri-25, Ri-20 and Ri-20-L | Masimo Corporation | DQA | Class II | |
| K081374 | Charlotte Lisfranc Bone Screw, Charlotte Lisfranc Plate | Wrightmedicaltechnologyinc | HRS | Class II | |
| K080776 | Gilras Slit Lamp, Models Gr-Sl7, Gr-Sl36, Gr-Sl54 and Gr-Sl72 | U.S. Ophthalmic, L.L.C. | HJO | Class II | |
| K080221 | Ea Stimulator | Helio Medical Supplies, Inc. | GZJ | Class II | |
| K073545 | Audicor, Hemo Ambulatory Monitor | Inovise Medical, Inc. | MWJ | Class II | |
| K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | IZI | Class II | |
| K071783 | Versapod (Tm) Instrument Trays | ContainMed, Inc. | KCT | Class II | |
| K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact | Kettenbach GmbH & Co KG | ELW | Class II | |
| K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak | Bio-Rad Laboratories Inc. | JJY | Class I | |
| K081623 | Synthes Rib Fixation System | Synthes (USA) Products LLC | HRS | Class II | |
| K081547 | Bio-Med Soft Insulin Syringe: Models 1Cc, 0.5Cc, 0.3Cc | Bio-Med USA, Inc. | FMF | Class II | |
| K081241 | Weigao Empty Cartridge Syringe | ShanDong WeiGao Group Medical Polymer Co., Ltd | FMF | Class II | |
| K081151 | Compumedics Neuvo | Compumedics USA, Inc. | GWQ | Class II | |
| K081013 | Microscan Dried Gram-Positive Mic/combo Panels New Antimicrobial Test Cefoxitin Screen | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K080116 | Transonic Costatus Cardiac Output System | Transonic Systems Inc | DXG | Class II | |
| K082426 | Renasys Ez | Smith & Nephew, Inc. | OMP | Class II | |
| K082383 | Fortoss Vital | Biocomposites, Ltd. | LYC | Class II | |
| K082216 | Tbd Ethicon Mesh | Ethicon, Inc | FTL | Class II | |
| K082144 | Amicas Pacs, Version 6.0 | Amicas, Inc. | LLZ | Class II | |
| K081961 | 3M Unitek Lava Chairside Oral Scanner | Brontes Technologies | NOF | Class II | |
| K081913 | Metacem, Meta P&bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | EMA | Class II | |
| K081747 | Modification to Synthes (USA) Condylar Head Add-on System | Synthes (USA) Products LLC | NEI | Class II | |
| K081702 | Carboxylate Cem, Phosphate Cem | S & C Polymer GmbH | EMA | Class II | |
| K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages | Interbody Innovations, LLP | ODP | Class II | |
| K081518 | Ultrasound Video Bronchoscope, Model Eb-1970Uk | PENTAX of America, Inc. | EOQ | Class II | |
| K081455 | Rayner Single Use Small Incision Disposable Injector, Model R-Inj-06 | Rayner Surgical, Inc. | MSS | Class I | |
| K081357 | 5Mp Grayscale Flat Panel Display, Model, 6Gf6201-5C$2# (Where $ = a-Z and # = 0-9) | Eizo GmbH | LLZ | Class II | |
| K081277 | Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Cons0le (Ipc) | Medtronic Xomed, Inc. | ERL | Class II | |
| K081225 | Cardica Pas-Port Proximal Anastomosis System | Cardica, Inc. | FZP | Class II | |
| K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | Smith & Nephew, Inc. | PHX | Class II | |
| K080960 | Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models Bgms:70900-03, 70090-02, G3ch Strips | Abbott Medical | NBW | Class II | |
| K080531 | Conmed Linvatec Microfracture Instrument Sterilization Tray | Conmed Linvatec | KCT | Class II | |
| K080435 | Olympus Direct Bilirubin Reagent, Model Osr6x181 | Olympus Life Science Research Europa GmbH (Europa) | CIG | Class II | |
| K080332 | Polyflex Stent System with Delivery System, Model M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | Boston Scientific Corporation | ESW | Class II | |
| K080196 | Z3d Contrast Acuity | Clario Medical Imaging, Inc. | LLZ | Class II | |
| K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee Unlimited | Brainlab, Inc. | HAW | Class II | |
| K071803 | Ards Dental Implants | Ards, Ltd. | DZE | Class II | |
| K082235 | Blackstone Pillar Xl Peek Spacers | Blackstone Medical, Inc. | MAX | Class II | |
| K082206 | Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models Dv-1600 Series, Dv-2000 Series | Freudenberg Medical, LLC | EWL | Class II | |
| K081601 | Veo Multigas Monitor for Pocket Pc | Phasein AB | CCK | Class II | |
| K080992 | Aesculap Implant Systems High Tibial Osteotomy Plating System | Aesculap Inc | HRS | Class II | |
| K080412 | Absorbable Synthetic Suture with Needle Attachment (Pga Braided) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | GAM | Class II | |
| K080089 | Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips | Sybron Dental Specialties, Inc. | ELC | Class II | |
| K070488 | Micardia Annuloplasty Band Dr | Micardia Corporation | KRH | Class II | |
| K070250 | Nutritone Facial Beauty System | Isomers Laboratories, Inc. | NFO | Class II | |
| K082195 | Modifications to Expedium Spine System | DePuy Spine, Inc. | NKB | Class II |