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 |
|---|---|---|---|---|---|
| K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | FRG | Class II | |
| K062484 | Flaem Nuova Rf6 Basic and Rf6 Plus Nebulizers | Flaem Nuova S.p.A. | CAF | Class II | |
| K071140 | MRI Compatible Thigh Tourniquet, Model C070002 | Top Spins, Inc. | KCY | Class I | |
| K071109 | Sacs EEG Workstation A7 | Sacs Medical AB | GWQ | Class II | |
| K070926 | Electrode/extension Cables, Models Atar | Oscor Inc. | IKD | Class II | |
| K070880 | Er35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | EWO | Class II | |
| K070842 | Ulceloocin Oral Ulcer Patch | Sunshine International Group, Inc. | OLR | Unclassified | |
| K070760 | Powder Free Chlorinated Latex Patient Examination Glove | Derma Care Plus Products, LLC | LYY | Class I | |
| K070723 | Futurabond Dc/single Dose | Voco GmbH | KLE | Class II | |
| K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer GmbH | KRR | Class II | |
| K070395 | Kd-525E Fully Automatic Electronic Blood Pressure Monitor | Kodon(Tianjin)Electronic&Electrical Apparatus Co. | DXN | Class II | |
| K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | KDI | Class II | |
| K063740 | V.a.c. Therapy Systems - Info V.a.c. Therapy Uniy, Model M6257766 | KCI USA, Inc. | OMP | Class II | |
| K063692 | V.a.c. Therapy Systems-Acti V.a.c. Therapy Unit Model# 340000 | KCI USA, Inc. | OMP | Class II | |
| K063685 | Optecure; Optecure + Ccc | Exactech, Inc. | MBP | Class II | |
| K063008 | Health Check Kiosk | Xperex Corporation | DXN | Class II | |
| K062902 | Pajunks Epilong Set Pediatric | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K062541 | Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens | Innova Vision Inc. | LPL | Class II | |
| K061956 | Artelon Stt Spacer | Artimplant AB | KYI | Class II | |
| K071143 | Bd Tritest Cd3/cd4/cd45, Model 340383 | Becton, Dickinson and Company, BD Biosciences | GKZ | Class II | |
| K071142 | Ge Datex-Ohmeda Avance Anesthesia System | GE Healthcare | BSZ | Class II | |
| K071141 | Bd Tritest Cd3/cd4/cd45 with Bd Trucount Absolute Count Tubes, Model 340402 | Becton, Dickinson and Company, BD Biosciences | GKZ | Class II | |
| K070946 | Synthes Lcp Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | MBL | Class II | |
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2) | Siemens Hearing Instruments, Inc. | ETW | Class II | |
| K071386 | Amaris/amaris Flow | Voco GmbH | EBF | Class II | |
| K071249 | Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov | Ethicon, Inc | FTL | Class II | |
| K071158 | Auralay Pit & Fissure Sealant | Denali Corporation | EBC | Class II | |
| K070878 | Datatherm II Continuous Temperature Monitor, Model Kd-2300 | Rg Medical Diagnostics | FLL | Class II | |
| K070633 | Genie, Model Ch-200 | Abbott Medical | FMF | Class II | |
| K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 | Abbott Medical | DYB | Class II | |
| K060434 | Abx Pentra Albumin Cp, Abx Pentra Micro-Albumin Cp, Abx Pentra Total Protein Cp, Abx Pentra Multical | Horiba Abx | CIX | Class II | |
| K070951 | 2Cm Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems | Boston Scientific Corporation | PNO | Class II | |
| K070835 | Olympus Ck-Mb Reagent | Olympus Life & Material Science Europa GmbH (Irish | JHY | Class II | |
| K070566 | Infinity Delta/delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/sc8000/ Sc9000xl | Draeger Medical Systems, Inc. | MHX | Class II | |
| K062112 | Sunmed Foley Catheters | Sunmed, Inc. | EZL | Class II | |
| K071358 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | NCX | Class II | |
| K071283 | Synchron Systems Creatinine Reagent | Siemens Healthcare Diagnostics Inc. | CGX | Class II | |
| K071280 | Synchron Cx Delta Clinical Systems, Creatinine Test Systems | Siemens Healthcare Diagnostics Inc. | CGX | Class II | |
| K071277 | Synchron Lx20 Clinical Systems, Creatinine Test Systems | Siemens Healthcare Diagnostics Inc. | CGX | Class II | |
| K071246 | Micrus Microcoil Delivery System, Models Sph, Hel, Che, Pc4, Hsr, Fsr, Csp, Cfs, Src, Pp4, Str | Micrus Endovascular Corporation | HCG | Class II | |
| K071237 | Copios Bone Void Filler Sponge and Paste | DSM Biomedical, Inc. | MQV | Class II | |
| K071220 | Columbus Total Knee System as | Aesculap Inc | JWH | Class II | |
| K071086 | Resolutionmd Cardiac Product Family, Model: Release 1.0 | Calgary Scientific, Inc. | LLZ | Class II | |
| K070991 | Vita Cad-Temp for Inlab, Model, Vx59-4002, Vx59-4010, Vx59-4102, Vx59-4110, Vx59-4202, Vx59-4210, Vx59-4302, Vx59-4310 | Vita | EBG | Class II | |
| K070939 | Self-Cath Cs Closed Urinary Catheterization System | MEDLINE INDUSTRIES, LP - Northfield | FCM | Class II | |
| K070864 | Boneplast Qs Calcium Sulfate Bone Void Filler | Biomet Osteobiologics | MQV | Class II | |
| K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 | Vascular Solutions LLC | DQY | Class II | |
| K070095 | Triathlon Ts Knee System | Howmedica Osteonics Corp | JWH | Class II | |
| K063699 | Imdx Systems | Novx Systems, Inc. | DJG | Class II |