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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K834371 | Tri-Count 10 | Hematology Marketing Assoc. | JPK | Class II | |
| K834269 | Ams Gram-Negative Ident. Card | Vitek Systems, Inc. | JTO | Class I | |
| K834209 | Stratus Thyroid Uptake Fluorometric | American Dade | KHQ | Class II | |
| K834149 | Autogrouper 16C Sys Automated Reag | Technicon Instruments Corp. | GMQ | Class II | |
| K833978 | Omega 5000 | Invivo Research Labs, Inc. | DXN | Class II | |
| K834146 | Anthroscopy System | Cabot Medical Corp. | HRX | Class II | |
| K840988 | No Pour Basin | Concord Laboratories, Inc. | |||
| K832678 | Phonatory Function Analyzer Ps-77 | Kells Medical, Inc. | BXP | Class I | |
| K832363 | Foley Catheterization Tray-Various | Inmed Corp. | KOD | Class II | |
| K840982 | Laser Mirror | American V. Mueller | |||
| K840683 | Fpp IV Secure | Fpp, Inc. | KMK | Class I | |
| K840388 | Pab IV Container | American Mcgaw | KPE | Class II | |
| K840273 | Lopez Lock | Abbott Medical | FPA | Class II | |
| K840212 | Concentrated Platelet Admin. Set | American Mcgaw | FPA | Class II | |
| K840192 | Piston Syringe Dispos. Sterile Syring | Interexpo Corp. | FMF | Class II | |
| K840007 | Surgical Suction Instrument-Reusable | Lawton Surgical Instruments | JOL | Class II | |
| K834553 | Intradiscal Therapy Tray | BD Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | |
| K834548 | Hypodermic Syringes & Needles | Cordis US Corp. | FMF | Class II | |
| K834540 | Op-Con Surgical Instrument #9 | Imm Enterprises, Ltd. | KBN | Class I | |
| K834497 | Shofu Porcelain Stain | Shofu Dental Corp. | EIH | Class II | |
| K834364 | Crystalline Bone Screw Endo-Osseous | C.B.S. Biotechnics, Inc. | DZE | Class II | |
| K834190 | Jakobi Surg. Instruments #8 15 | Imm Enterprises, Ltd. | EMH | Class I | |
| K834189 | Jakobi Surg. Instruments #7 44/47 | Imm Enterprises, Ltd. | EPY | Class I | |
| K834188 | Jakobi Surg. Instruments #7 10/43 | Imm Enterprises, Ltd. | JYL | Class I | |
| K834172 | Op-Con Surg. Instrument #7 | Imm Enterprises, Ltd. | EQN | Class II | |
| K834091 | Silcath | Hdc Corp. | LJS | Class II | |
| K834044 | Medi-Jector II | Derata Corp. | KZE | Class II | |
| K833672 | Hh Subcutaneous Access Port | Holter-Hausner Intl. | LKG | Class II | |
| K833398 | Mesulin Insulin Infusion Set | Molnlycke A/S Hospital Products | FPA | Class II | |
| K832906 | Port-a-Cath Implantable Catheter Sys | Pharmacia, Inc. | LLD | Class II | |
| K840741 | Pulmonary Function Testing Sts | Circadian, Inc. | BZG | Class II | |
| K840724 | Muscle Stimulator X-10 | Biostim, Inc. | IPF | Class II | |
| K840607 | Lf Motorized Radiographic Film Viewer | Sybron Corp. | IXC | Class I | |
| K840556 | Disposable Syringe Filters | Corning Medical & Scientific | KET | Class I | |
| K840477 | Unitized Hematology Set 65132/93 | EMD Millipore Corporation | GIF | Class I | |
| K840424 | Hemocath Repair Kit | Quinton, Inc. | KNZ | Class II | |
| K840413 | Cement Restrictor | American Ortomed Corp. | JDK | Class II | |
| K840325 | Infa Complete Breast Pump & Milk Storag | Monterey Laboratories, Inc. | HGY | Class I | |
| K840308 | Cat. 4-Obstetrics Gynecology Dev's | Imm Enterprises, Ltd. | KOH | Class I | |
| K840289 | Lyse-Tec | Medilab Corp. | GGK | Class I | |
| K840239 | Voflex | Dhd Medical Products Div. Diemolding Corp. | BWF | Class II | |
| K840178 | Appose Dispos. Skin Stapler W/auto | Davis & Geck, Inc. | GAG | Class II | |
| K840177 | Appose Ule Sterile Dispos. Skin Stap | Davis & Geck, Inc. | GAG | Class II | |
| K840089 | Skin Staple Remover | Mediquest, Inc. | |||
| K840041 | Sdi Prepax Dilukit Hw | Scientific Distributors, Inc. | GIF | Class I | |
| K834614 | Wilcor-Xr Rp-L Medical Film | Cea America Corp. | IWZ | Class I | |
| K834613 | Wilcor-Xr Rp Medical Film | Cea America Corp. | IWZ | Class I | |
| K834573 | Aqua Trap | Airlife, Inc. | BYH | Class I | |
| K834570 | Volume Ventilator Circuit W/water Trap | Airlife, Inc. | BZO | Class I | |
| K834483 | Digi-X | Radiation Measurements, Inc. | LHO | Class I |