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 |
|---|---|---|---|---|---|
| K023453 | Depuy Summit Fx Cemented Hip Prosthesis | Depuy Orthopaedics Inc. | JDI | Class II | |
| K023438 | Modification to Monarch Spine System | Depuyacromed | MNH | Class II | |
| K023433 | Varelisa Cardiolipin Antibodies Screen, Models 15848 and 15896 | Pharmacia Diagnostics GmbH & Co. KG | MID | Class II | |
| K023431 | Quantix/nd Device | Cardiosonix, Ltd. | DPW | Class II | |
| K023283 | 1075Ld Hush-Slush | O.R. Solutions, Inc. | LHC | Class I | |
| K023282 | Ors-3000Ld | O.R. Solutions, Inc. | LHC | Class I | |
| K023153 | Micro-Touch Next Step Powder Free Medical Examination Gloves with Aloe and Glycerol | Ansell Healthcare Products LLC | LYY | Class I | |
| K023054 | Jia Chen Acupuncture Needle, for Single Use | Mandala Health Care, LLC | MQX | Class II | |
| K023008 | Universal System, Model Qv-800 | Quantum Medical Imaging, LLC | KPR | Class II | |
| K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (USA) Products LLC | KWQ | Class II | |
| K022784 | Syntex Powder-Free Nitrile Examination Glove, Purple Color | Syntex Healthcare Products Co., Ltd. | LZA | Class I | |
| K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | JJX | Class I | |
| K022768 | Amt Polyaxial Pedicle Screw | Micron Precision Engineering, Inc. | MNI | Class II | |
| K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | IKN | Class II | |
| K022501 | Instant-View Mdma (Ecstasy, Xtc) Urine Test | Alfa Scientific Designs, Inc. | DJC | Class II | |
| K022059 | Microvasive Pulmonary Guidewire | Boston Scientific Corporation | MDM | Class I | |
| K021585 | Stellar Series Surgical Lights with Hermes | Skytron, LLC | FSY | Class II | |
| K021060 | Fresenius Icare Monitoring System | Fresenius Medical Care Renal Therapies Group, LLC | FKP | Class II | |
| K020703 | Scorpio Cr and Ps Co Cr Femoral Components with Titanium Plasma Spray Coating | Howmedica Osteonics Corp | JWH | Class II | |
| K014050 | Hex-Lock Temporary Abutment | Sulzer Dental, Inc. | DZE | Class II | |
| K023629 | Essex Dissection Cannula, Model Sxd-1100, Essex Dissection Tip, Model Sxd-1200 | Guidant Corporation, Cardiac Surgery | GCJ | Class II | |
| K023627 | Essex Endoscope, Model Sxd-1000 | Boston Scientific Corporation | GCJ | Class II | |
| K023444 | Bd Phoenix Automated Microbiology System-Amikacin-0.5-64 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K023301 | Bd Phoenix Automated Microbiology System | Becton Dickinson & Co | LON | Class II | |
| K023236 | Sensicare -C Synthetic Polyisoprene Powder-Free Surgical Gloves | Maxxim Medical | KGO | Class I | |
| K023159 | Midas Touch Blue Latex Examination Gloves - Poeder Free | Industrial Clothings, Ltd. | LYY | Class I | |
| K022712 | Hand Drill, Model 11-9901-7 | Medical Design, LLC | HBG | Class II | |
| K022708 | Klarity | Larson Products, Inc. | IYE | Class II | |
| K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model Da Vinci Isi 1000/1200 | Intuitive Surgical, Inc. | NAY | Class II | |
| K022178 | Ca 15-3 Assay for the Advia Integrated Modular System | Bayer Diagnostics Corp. | MOI | Class II | |
| K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | Medrad, Inc. | MOS | Class II | |
| K023590 | Powdered Natural And/or Colored Latex Exam Gloves | Yty Industry (Manjung) Sdn. Bhd. | LYY | Class I | |
| K023518 | Ecat Lso Pet/ct 16 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K023507 | Modification to Gelbfish Vascular Dilators | Vascumetrix, LLC | DRE | Class II | |
| K023416 | Modification to Vks Knee System | Plus Orthopedics | JWH | Class II | |
| K023413 | Modification to Neothermia's En-Bloc Biopsy System | Neothermia Corp. | GEI | Class II | |
| K023409 | Ha X-Series Bi-Metric Hip Femoral Components | Zimmer GmbH | LPH | Class II | |
| K023398 | Hologic Qdr X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | Hologic, Inc. | KGI | Class II | |
| K023266 | Primagard Surgical Gowns | Primeline Medical Products, Inc. | FYA | Class II | |
| K023206 | Sperm Cryoprotec | Nidacon International AB | MQL | Class II | |
| K023117 | Primagard Surgical Gowns | Primeline Medical Products, Inc. | KKX | Class II | |
| K022868 | Primagard Surgical Equipment Drapes | Primeline Medical Products, Inc. | KKX | Class II | |
| K022672 | Columbus Total Knee System (Cr) | Aesculap Inc | JWH | Class II | |
| K022572 | Nitri Grip Powdered Nitrile Examination Gloves | Ar Alliance Healthcare Sdn. Bhd. | LZA | Class I | |
| K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | INK | Class II | |
| K021925 | Sunpex Technologies Model Se 01 | Sunpex Technology Co., Ltd. | INI | Class II | |
| K021477 | Preclude Mvp Dura Substitute | W. L. Gore & Associates, Inc. | GXQ | Class II | |
| K021247 | Pneumoperitoneum Insufflation Needle | Mectra Labs, Inc. | HIF | Class II | |
| K021240 | Eikon Automatic Digital Blood Pressure Monitor, Model Hd-200M/hd-200 | Eikon Healthcare Device Corp. | DXN | Class II | |
| K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model Hd-400M | Eikon Healthcare Device Corp. | DXN | Class II |