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 |
|---|---|---|---|---|---|
| K093472 | Trinity Acetabular System | Corin USA | MEH | Class II | |
| K103263 | Endo Gia Singleuse Duet Trs Reload with Tri0staple Technology | Covidien, Formerly US Surgical A Divison of Tyco H | GDW | Class II | |
| K103104 | Special Orthopaedic Solutions Glenoid Shoulder Component | Howmedica Osteonics Corp | KWS | Class II | |
| K102620 | Powderfree Black Nitrile Examination Gloves | PT. Medisafe Technologies | LZA | Class I | |
| K102519 | Flexstent Biliary Self Expanding Stent System Model Flx-Ddlll-Bx | Flexible Stenting Solutions, Inc. | FGE | Class II | |
| K102444 | Powder-Free Vinyl Patient Examination Gloves | Zibo Yingbo Medical Products, Inc. | LYZ | Class I | |
| K102308 | Simpleline II Model Sofx483408r, Sofx483410r Total 44 Models | Dentium Co., Ltd. | DZE | Class II | |
| K102217 | System 1E Chemical Indicator | STERIS Corporation | JOJ | Class II | |
| K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428 | Smith & Nephew, Inc. | KCT | Class II | |
| K102114 | Medrange Electrosurgical Generator | Medrange Corporation | GEI | Class II | |
| K101817 | Lightwalker at, Model M021-5Af/1, Lightwalker Dt, Model M021-5Af/2, Lightwalker St-E, Model M002-6A/2, Lightwalker St-N | Fotona D.D. | GEX | Class II | |
| K101755 | Aidi Dental Implant System | Aidi Biomedical, LLC | DZE | Class II | |
| K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | Henke-Sass Wolf, GmbH. | FMF | Class II | |
| K093055 | Csts Screw | Orthopro, LLC | HWC | Class II | |
| K103124 | Series II X3 Large Diameter Accetabular Inserts | Stryker Corp. | LPH | Class II | |
| K103118 | Revlite Q-Switched Nd: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | GEX | Class II | |
| K103090 | Spectra Optia R Apheresis System | Terumo BCT, Ltd | LKN | Unclassified | |
| K103057 | Asahi Astato Xs 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K102923 | Barrier N95 Particulate Respirator | Molnlycke Health Care | MSH | Class II | |
| K102880 | Brightway Tm Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color) | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | OCX | Class II | |
| K102612 | Voco Ionofil Molar Ac Quick | Voco GmbH | EMA | Class II | |
| K102390 | Sonosite Nanomaxx Series Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K102257 | Nanoceram- Bright | Dmp, Ltd. | EBF | Class II | |
| K102147 | Cardioquip Modular Cooler-Heater Model Mch-1000 | CardioQuip | DWC | Class II | |
| K102015 | Osteon, Osteon Sinus, Osteon Lifting | GENOSS Co., Ltd. | LYC | Class II | |
| K102010 | Vacuette Premium Safety Blood Collection Set | Medpro Safety Products, Inc. | FMI | Class II | |
| K101940 | Equashield System Protective Plus | Equashield Medical Ltd | LHI | Class II | |
| K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Sgmp Co., Ltd. | LZC | Class I | |
| K100598 | Penrith Elettra Ultrasound System | Penrith Corporation | IYN | Class II | |
| K100185 | Sleep App | Sleep Medicine Network, Inc. | LRK | Class II | |
| K094016 | Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model Huckcr17x27mh, H | Hinson and Hale Medical Technologies, Inc. | KKX | Class II | |
| K093495 | Otoscope and Ophthalmoscope Diagnostic Instrument Kits | American Diagnostic Corp. | HLJ | Class II | |
| K092745 | Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and Heat Seal Pouches, Heat Seal Tu | STERIS Corporation | KCT | Class II | |
| K092728 | 20.1 Inch (51 Cm) Color Lcd Monitor Ccl208 (Cdl2013a) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K103162 | Elecsys Pth Calcheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K102615 | Wireless Dr Imaging Option-Wdr1 | GE Healthcare | MQB | Class II | |
| K102433 | Moorvms-Pres Pressure Cuff Controller | Moor Instruments Ltd. | DPW | Class II | |
| K102377 | Ventiplus Disposable Manometer 0-60 Cm H2o; Ventiplus Disposable Manometer 0-20 Cm H2o; Ventiplus Disposable Manometer 0 | A Plus Medical | CAP | Class II | |
| K102365 | Microplex Coil System- Cosmos | Terumo Cardiovascular Systems Corporation | KRD | Class II | |
| K102236 | Hovertrans Transformer with Power Drive Model Htt-650P | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | INK | Class II | |
| K102146 | Bahadir Sterilization Trays | Bahadir USA LLC | KCT | Class II | |
| K102112 | Criticool Pro | Mtre Advanced Technology, Ltd. | DWJ | Class II | |
| K102083 | Velscope Vx | LED Dental Inc. | NXV | Class II | |
| K102043 | Ultrastream Chronic Hemodialysis Catheter | Rex Medical LP | MSD | Class II | |
| K101368 | D. Heart Medical Intravascular Administration Set, Safety Acces Device and Accessories | Dragon Heart Medical, Inc. | FPA | Class II | |
| K101244 | Skin Sensor Probe, General Purpose Probe, Tympanic Probe | Truer Medical, Inc. | FLL | Class II | |
| K101133 | Sensometrics Software | Dpcom AS | GWM | Class II | |
| K101031 | Masimo Disposable Oximetry Ear Sensor, Model E1 | Masimo Corporation | DQA | Class II | |
| K100720 | K-Shield Port Access Infusion Set with High Pressure Tubing | Kawasumi Laboratories Co., Ltd. | FPA | Class II |