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 |
|---|---|---|---|---|---|
| K052841 | Mira-Flex 18 Microcatheter | Cook Inc. | KRA | Class II | |
| K052490 | Endosseous Dental Implant System | Northern Implants, LLC | DZE | Class II | |
| K052451 | Mps Acacia Medflo Elastomeric Pump | Mps Acacia | MEB | Class II | |
| K052428 | Resolution Endovascular System | Omnisonics Medical Technologies | QEY | Class II | |
| K052221 | Ambit Push & Play Ambulatory Infusion Pump | Sorenson Medical, Inc. | FRN | Class II | |
| K052023 | Cadimas Version 1.0 | Alan Penn & Associates., Inc. | LNH | Class II | |
| K051300 | Robin Hood Vest | Kamber Corporation | FRP | Class I | |
| K053325 | Mediwatch Multiscan Ultrasound System/scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System, Model M0001 | Mediwatch PLC | IYO | Class II | |
| K053281 | Evms (Enterprise Visual Medical System Software) | Merge Healthcare Incorporated | LLZ | Class II | |
| K053202 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K053200 | Gore Seamguard Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model Csp & Che | Micrus Endovascular Corporation | HCG | Class II | |
| K053119 | Distal Radio-Ulnar Joint Implant | Aptis Medical, LLC. | KXE | Class II | |
| K053093 | Kalix II Implant, Model 141 0Xx with Xx | New Deal, S.A. | HWC | Class II | |
| K053031 | Extendsure Hbfasc Control | Cantebury Scientific, Ltd. | JCM | Class II | |
| K052426 | Smith & Nephew Modular Hip | Smith & Nephew, Inc. | MEH | Class II | |
| K052398 | Mesa Spinal System | K2M, Inc | MNI | Class II | |
| K052343 | E-San Bluetooth Cradle | E-San Limited | NBW | Class II | |
| K052275 | Smith & Nephew Platform Hip Stem | Smith & Nephew, Inc. | LZO | Class II | |
| K052249 | Utopia | Respcare, Inc. | BZD | Class II | |
| K052151 | Synthes Pangea Monoaxial System | Synthes Spine Co.Lp | NKB | Class II | |
| K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model Bgp-100 | Sein Electronics Co., Ltd. | NBW | Class II | |
| K051733 | Enzyme Immunoassay for the Detection of Salivary Cortisol | Drg Intl., Inc. | NHG | Class II | |
| K051714 | Total Bile Acids Assay, Model Dz042a | Diazyme Laboratories, Inc. | KWW | Class II | |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System | Medrad, Inc. | GKL | Class II | |
| K051513 | Bipore Accuflex Percutaneous Sheath Introducer | Bipore, Inc. | DYB | Class II | |
| K053297 | Arthrocare 8000S Coblator Surgery System | ArthroCare Corporation | GEI | Class II | |
| K053115 | Xia Spinal System | Howmedica Osteonics Corp | MNI | Class II | |
| K052962 | Optimized Barb Design | Surgical Specialties Corp | GAW | Class II | |
| K052888 | Porous Titanium Acetabular Augments | Biomet Manufacturing Corp | KWA | Class III | |
| K052738 | Infusioncath Peripheral Infusion Catheter, Models Vf0012, Vf0016, Vf0024, Vf0028, Vf0032, Vf0036, Vf0040, Vf0044 | Veinrx, Inc. | KRA | Class II | |
| K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | LPL | Class II | |
| K051911 | Gelita-Spon | Curamedical, BV | KHJ | Class II | |
| K051638 | Inverness Medical Testpack + Plus Strep a with Obc | Unipath, Ltd. | GTY | Class I | |
| K051371 | Interbody Innovations Cement Restrictor | Interbody Innovations, LLP | JDK | Class II | |
| K051101 | Verify Flash Integrator | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K050526 | Polymer Coated Online Chlorinated Powder Free Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or | Spi Gloves Sdn. Bhd. | LYY | Class I | |
| K053192 | Model 418 Series Walkers | MJM International Corporation | NXE | Class I | |
| K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K053007 | Skylark Uro Probe | Skylark Device & Systems Co., Ltd. | KPI | Class II | |
| K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | LLZ | Class II | |
| K052728 | Powder Free Latex Sterile Patient Examination Gloves | M/S. Kanam Latex Industries Pvt., Ltd. | LYY | Class I | |
| K052683 | Synthes (USA) Sternal Fixation System | Synthes (USA) Products LLC | HRS | Class II | |
| K052644 | Swartz Braided Transseptal Guiding Introducer | Abbott Medical | DYB | Class II | |
| K052625 | Bionicare Stimulator System, Model Bio-1000 | Bionicare Medical Technologies, Inc. | NYN | Class II | |
| K052572 | Anspach Knotless Anchor | The Anspach Effort, Inc. | MBI | Class II | |
| K052445 | Duopross Needle | Duopross Meditech Corporation | FMI | Class II | |
| K052026 | Lineage a-Class Poly Liner | Wrightmedicaltechnologyinc | LPH | Class II | |
| K051484 | Zeus Scientific, Inc., Athena Multi-Lyte Mmrv Igg Test System. | Zeus Scientific LLC | LFY | Class II | |
| K051382 | Elecsys Probnp Immunoassay | Roche Diagnostics GmbH | NBC | Class II |