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 |
|---|---|---|---|---|---|
| K090060 | Nexlink Oct System, Model 7000 Series | Spinal Concepts, Inc. | KWP | Class II | |
| K090034 | Easy on-Pc Spirometer | Ndd Medizitechnik AG | BZG | Class II | |
| K083917 | X-Ray, Tomography, Computed, Dental | Suni Medical Imaging, Inc. | OAS | Class II | |
| K083057 | I-Max Touch | Owandy Inc. | MUH | Class II | |
| K082166 | Mastergraft Strip | Medtronic Sofamor Danek | MQV | Class II | |
| K091322 | Contour Curved Cutter Stapler and Reloads, Models: Cs40b, Cs40g, Cr40b, Cr40g | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K091151 | Powder Free Nitrile Examination Glove, Green Tea Scented, Green | Gx Corporation Sdn Bhd | LZA | Class I | |
| K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International SA | HWC | Class II | |
| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771 | Siemens Healthcare Diagnostics Inc. | DKB | Class II | |
| K090632 | Compex Rehab | Chattanooga Group, Inc. | IPF | Class II | |
| K090566 | Pathway Avid | Custom Spine, Inc. | MAX | Class II | |
| K090525 | Loi System | Palomar Medical Products, Inc. | ONG | Class II | |
| K090415 | Eminent Spine Buttress (Fang) Plate System | Eminent Spine | KWQ | Class II | |
| K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,white). | Gx Corporation Sdn Bhd | LZA | Class I | |
| K083899 | Revlite Q-Switched Nd:yag Laser System | Hoya Conbio, Inc. | GEX | Class II | |
| K091436 | Digital Radiography, Model Cxdi-55C | Canon, Inc. | MQB | Class II | |
| K091435 | Digital Radiography Model Cxdi-55G | Canon, Inc. | MQB | Class II | |
| K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K091271 | Respironics Performax Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | BZD | Class II | |
| K091254 | The Crosser 14 Otw Catheter, Model Cru014 | Flowcardia, Inc. | DQY | Class II | |
| K090831 | Tanthera-T35 | Tanthera, Inc. | LEJ | Class II | |
| K090432 | Hemorpex System | Angiologica B. M. SRL | FER | Class II | |
| K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | NFB | Class II | |
| K090383 | Sri Level II Surgical Gown | SRI Healthcare, LLC | FYA | Class II | |
| K090282 | Qms Lidocaine | Thermo Fisher Scientific Oy | KLR | Class II | |
| K090052 | Cranial Electrical Nerve Stimulator, Model Fm 10/C | Johari Digital Healthcare, Ltd. | QJQ | Class II | |
| K083598 | Karl Storz Voice1 Scb R-Ui Speech Control Application | Karl Storz Endoscopy-America, Inc. | ODA | Class II | |
| K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy Drugs | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K082436 | Extt-101 | Apimeds, Inc. | HIR | Class II | |
| K081147 | Isoflow Infusion Catheter | Vascular Designs, Inc. | KRA | Class II | |
| K091358 | Ecscope 100 | Dyansys, Inc. | DPS | Class II | |
| K090979 | Disposable Handle Assembles, Models Dh0100 and Dh0500 Series | Encision, Inc. | GCJ | Class II | |
| K090957 | Blackrock Neuroport Biopotential Signal Processing System | Blackrock Microsystems | GWL | Class II | |
| K090700 | Immunocard Stat Campy, Model 751530 | Meridian Bioscience Inc | LQP | Class I | |
| K090602 | Cardiodynamics Bioz Rx, Model 7101-Sys | Cardiodynamics International Corp. | DSB | Class II | |
| K090528 | Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit | C.R. Bard Inc | MSD | Class II | |
| K090458 | Dexis Sensor | Dexis, LLC | MUH | Class II | |
| K090262 | Percucath Urinary Catheter | Percuvision, LLC | EZL | Class II | |
| K090071 | Rostam Ltd. Fragranced or Unfragranced New Plastic Applicator Tampons | Rostam, Ltd. | HEB | Class II | |
| K083117 | Elia Rnp70 Immunoassay, Elia Sci-70 Immunoassay and Elia Jo-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 | Phadia AB | LKO | Class II | |
| K081769 | Innovance Antithrombin with Models Opfh03, Opfho5 | Siemens Healthcare Diagnostics Inc. | JBQ | Class II | |
| K091326 | Activapatch | Activatek, Inc. | EGJ | Class II | |
| K091212 | Wu's 3 Wheeled Electrical Scooter, Wt-T3h | Wu's Tech Co., Ltd. | INI | Class II | |
| K091195 | Philips Mx 16 Slice CT System Phase11, Model 9896 056 56511 | Philips North America LLC | JAK | Class II | |
| K091145 | Flexiplan 3D and 3D+ | Isodose Control B.V. | MUJ | Class II | |
| K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | FYA | Class II | |
| K091050 | 506Cn Patient Monitor | Criticare Systems, Inc. | DRT | Class II | |
| K090943 | Abt Glucose Control Solution, Model: 2120089 | American Biological Technologies, Inc. | JJX | Class I | |
| K090880 | Xylos Porous Surgical Mesh | Xylos Corporation | FTM | Class II | |
| K090856 | Journey (or Rpsp), Journey Cubic (or Supra or Tp02) | Thyssenkrupp Ceteco SRL | ING | Class II |