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 |
|---|---|---|---|---|---|
| K031622 | Wallace Dual Lumen Oocyte Retrieval Sets | Abbott Medical | MQE | Class II | |
| K031591 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored), Blue and Green Colored | Perusahaan Getah Asas Sdn. Bhd. | LZA | Class I | |
| K031414 | Powder-Free Latex Patient Examination Glove, White (Non-Colored), or Blue Colored, with Extractable Protein Content Labe | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K031151 | Ts3 Tubing Set | Global Blood Resources, LLC | DWF | Class II | |
| K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane) | GE Healthcare | CAD | Class II | |
| K030995 | Minilok Quickanchor Plus | Mitek Worldwide | HWC | Class II | |
| K030581 | Blackstone Spinal Fixation System Lateral Offset (System Modification) | Blackstone Medical, Inc. | MNH | Class II | |
| K024181 | Prizm Medical, Inc. Micro-Z Stimulation System | Prizm Medical, Inc. | IPF | Class II | |
| K024000 | Metricath System Comprised of Metricath 1000 Console & Metricath Balloon Catheter | Angiometrx, Inc. | DQO | Class II | |
| K023011 | Osmonics Solution Delivery System | Osmonics Medical Systems | FIN | Class II | |
| K021328 | Smart Bag Mo | O-Two Systems International, Inc. | BTM | Class II | |
| K031781 | Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and Accessories | GE Healthcare | MHX | Class II | |
| K031756 | Roche Diagnostics Elecsys Folate II Assay | Roche Diagnostics GmbH | CGN | Class II | |
| K031682 | Lipoprotein Calibrator | Medrad, Inc. | JIX | Class II | |
| K031645 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K031644 | Bayer Advia Chemistry Special Chemistry Control | Medrad, Inc. | JJY | Class I | |
| K031505 | Rapido Cut-Away Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K031450 | Quanta Plex Ena Profile 6 | Inova Diagnostics, Inc. | LLL | Class II | |
| K031159 | Calibrating Material, Calibrating Standards | DIAMOND DIAGNOSTICS Inc | JIT | Class II | |
| K031010 | Miracle 98 | Sb Lucius, Inc. | EJT | Class II | |
| K030990 | Datex-Ohmeda Mini-Filter/s and Uni-Filter Junior | GE Healthcare | CAH | Class II | |
| K030708 | Slendertone Flex Abdominal Training System, Type 515 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K030035 | Irma Sl Blood Analysis System Cr Cartridge | Diametrics Medical, Inc. | JFY | Class II | |
| K023817 | Smartshape Body Composition Analyzer, Model 4010 | Clio Designs, Inc. | MNW | Class II | |
| K023367 | Detectar, Model N123-Mi | Neks Technologies, Inc. | EJB | Class I | |
| K014013 | H & W Hospital Ethylene Oxide Sterilizer Control System | H & W Technology, LLC | FLF | Class II | |
| K031864 | Nitrex Nitinol Guidewire | Medtronic, Inc. | DQX | Class II | |
| K031773 | Endo Gator System | Byrne Medical, Inc. | OCX | Class II | |
| K031725 | Synthes Ti-15 Mo Locking Distal Radius Plating System | Synthes (USA) Products LLC | KTT | Class II | |
| K031680 | Spectrapulse | Primary Technology, LLC | GEX | Class II | |
| K031595 | U & I America Spinal Hook System | U&I Corp., America | KWP | Class II | |
| K031572 | Zmr Hip System-Xl, Models 9921, 9922 and 9923 | Zimmer GmbH | LPH | Class II | |
| K031460 | Modification to Remstar Auto CPAP System | Respironics, Inc. | BZD | Class II | |
| K031393 | Bayer Advia Centaur Ca 19-9 Assay | Medrad, Inc. | NIG | Class II | |
| K031228 | Synvitro Hyadase | Medicult A/S | MQL | Class II | |
| K031200 | Modification to Bd Ultra-Fine III Pen Needle | Becton Dickinson & Co | FMI | Class II | |
| K031154 | Sintea Biotech Schanz Screw, Model Tfx.ss.xx.x | Sintea Biotech, Inc. | JDW | Class II | |
| K031096 | Modification to Transport Incubator 185 | International Biomedics, Inc. | FPL | Class II | |
| K030981 | Eclipse | Varian Medical Systems, Inc. | LNH | Class II | |
| K030875 | Modification to Colorado 2 Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K030578 | Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical System | Computer Motion, Inc. | NAY | Class II | |
| K024270 | Clear-Therm 3 Hmef, Clear-Therm 3 with Superset Catheter Mount,clear-Therm with Flexible Catheter Mount,clear-Guard 3 F3 | Intersurgical Ltd. | CAH | Class II | |
| K023955 | Bd Viper Instrument | Becton Dickinson & Co | JQW | Class I | |
| K023430 | Uf Brachytherapy Stand | University of Florida | IYO | Class II | |
| K023355 | Asyra | Galloway Technologies, LLC | GZO | Class II | |
| K031635 | Depuy Acromed Vbr System | Depuyacromed | MQP | Class II | |
| K031556 | Vivatherm Themperature Measurement System | Vivant Medical, Inc. | FLL | Class II | |
| K031350 | 3Tp Software Option | 3tp, LLC | LNH | Class II | |
| K031346 | Jovus Eagle Eye F/x 2.9F Ivus Catheter, Model 85900 | Jomed, Inc. | OBJ | Class II | |
| K031150 | Hemobag, Model Hbbsd2000 | Global Blood Resources, LLC | DTN | Class II |