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 |
|---|---|---|---|---|---|
| K073167 | Brainstat Software Option for Ge Signa Mr Scanner | GE Healthcare | LNH | Class II | |
| K073094 | Vitallink3 Mobile Vital Signs System | Telemedic Systems, Inc. | MWI | Class II | |
| K073029 | Proflu+ Assay | Prodesse, Inc. | OCC | Class II | |
| K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | NEU | Class II | |
| K072745 | Y-Glide | Merit Medical Systems, Inc. | DTL | Class II | |
| K072684 | Mondeal Endoscopic Tissue Recession and Release System | Mondeal North America, Inc. | OCZ | Class II | |
| K072615 | Txcontrol | ResMed Corp | BZD | Class II | |
| K072590 | Inspiration; Ventilator System, Ls Ventilator System, Infant Ventilator System and Infant Ls Ventilator System | Event Medical Ltd | CBK | Class II | |
| K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | LPL | Class II | |
| K071554 | Volcano S5/s5i Intravascular Imaging and Pressure System | Volcano Corporation | OBJ | Class II | |
| K070665 | Lithoskop | Siemens Medical Solutions USA, Inc. | LNS | Class II | |
| K070605 | Jostra Venous Softbag Reservoirs with and without Safeline Coating | MAQUET CARDIOPULMONARY GmbH | DTN | Class II | |
| K073517 | H-Link Integrated Rod | Globus Medical, Inc. | NKB | Class II | |
| K073242 | Portable Oxygen Concentrator, Model Rs-00400 | Delphi Medical Systems | CAW | Class II | |
| K073238 | Syngo Volume Perfusion-CT Neuro | Siemens AG Medical Solutions | JAK | Class II | |
| K073113 | Infinity Picco Pod, Model Ms16734 | Draeger Medical Systems, Inc. | DXG | Class II | |
| K073105 | Peek Spinal Spheres | Interbody Innovations, LLP | NVR | Class III | |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model Df270 | Siemens Healthcare Diagnostics Inc. | JFY | Class II | |
| K072914 | Natural Bridge Lp Transverse Connectors | K2M, Inc | MNI | Class II | |
| K072469 | Digiflo Concentrator Analyzer | Digiflo, Inc. | CCL | Class II | |
| K072395 | Diazyme Hdl-Cholesterol Reagent,calibrator, Controls | Diazyme Laboratories, Inc. | LBS | Class I | |
| DEN070013 | Id-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics Inc | OCC | Class II | |
| K073313 | Mark III Waveguide Fiber with Low Profile Tip | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K072751 | Cooltouch Models Ns 160 and Lc215 Coolipo | New Star Lasers, Inc. | GEX | Class II | |
| K071695 | Kensey Nash Macropore Shield | DSM Biomedical, Inc. | FTL | Class II | |
| K070789 | Euroimmun Anti-Ccp Elisa | Euroimmun US Inc. | NHX | Class II | |
| K073436 | Spectra Vrmii 1-Switched Nd:yag Laser System | Lutronic Corporation | GEX | Class II | |
| K073378 | Advance 18Lp Pta Dilatation Catheter | Cook Inc. | DQY | Class II | |
| K073221 | Cadence II | Edan Instruments, Inc. | HGM | Class II | |
| K072937 | Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set | Olsen Medical | GEI | Class II | |
| K072813 | Emma Analyzer (Kpa & Mmhg); Emma Monitor (Kpa & Mmhg) | Phasein AB | CCK | Class II | |
| K072718 | Penumbra System | Penumbra Inc. | NRY | Class II | |
| K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | NHA | Class II | |
| K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories | Prosurg, Inc | JEY | Class II | |
| K072105 | Alaris System with Mms, Model 8Xxx | Cardinal Health 303,Inc. | FRN | Class II | |
| K071905 | Posterior Cervicothoracic Spinal Fixation System (Pcfs) | Lanx, LLC | KWQ | Class II | |
| K071671 | Scanscope Xt System | Leica Biosystems Imaging, Inc. | OEO | Class II | |
| K070857 | Nobeldirect 3.0-Immediate Load, 3.0 X 13 Mm and 3.0 X 15 Mm | Nobel Biocare AB | DZE | Class II | |
| K070357 | Flexcath Steerable Sheath & Dilator | Medtronic CryoCath LP | DRA | Class II | |
| K063716 | Aerosol System | Amici, Inc. | CAF | Class II | |
| K073367 | Hemosil Fibrinogen-C | Instrumentation Laboratory Co. | KQJ | Class II | |
| K073237 | Rehastim & Rehamove | Hasomed GmbH | GZI | Class II | |
| K073178 | Hct Extended Hematology Control, Model Hct004 | R & D Systems, Inc. | JPK | Class II | |
| K072996 | Remstar Pro M-Series CPAP & Heated Humidifier System | Respironics, Inc. | BZD | Class II | |
| K072836 | Cholestrak Hdl Cholesterol Home Test | Accutech, LLC | LBS | Class I | |
| K072485 | Artiste Mv Sa | Siemens Medical Solutions USA, Inc. | IYE | Class II | |
| K072484 | Cynosure Yag Family Laser | Cynosure, LLC | GEX | Class II | |
| K072159 | Smart CO2 (Smartxide, Smart Us20d) with Dot Scanner | El.en. Electronic Engineering SpA | GEX | Class II | |
| K071886 | Self Seal Sterilization Pouch | Shanghai Jianzhong Medical Packaging Co., Ltd. | FRG | Class II | |
| K070012 | Polybone | Kyung Won Medical Co., Ltd. | GXP | Class II |