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 |
|---|---|---|---|---|---|
| K001886 | Apex Fixation Pins | Howmedica Osteonics Corp | JDW | Class II | |
| K001804 | Numed Z-5 Atrioseptostomy Catheter | Numed Inc | DXF | Class II | |
| K001794 | Ebi Anterior Cervical Plate System | Ebi, LLC | KWQ | Class II | |
| K001587 | 19 Ga Plastic Reinforced Epidural Catheter | Arrow Intl., Inc. | CAZ | Class II | |
| K001524 | Forma Scientific Direct Heat Incubators | Thermoquest Corp. | MQG | Class II | |
| K001516 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K001502 | Aerosol Provocation System Aps Pro, Model Aps Pro | Erich Jaeger, Inc. | BZC | Class II | |
| K001421 | Ontrak Testcup 501, Model 3016633 | Roche Diagnostics GmbH | DKZ | Class II | |
| K001401 | Amt Therapeutic Table, Model 748Amt | Amt Mfg., Inc. | ITH | Class II | |
| K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System | Intuitive Surgical, Inc. | NAY | Class II | |
| K001863 | Synthetic Powdered (White) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K001861 | Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | LYZ | Class I | |
| K001837 | Nitrile Examination Gloves, Pre-Powdered, Color Blue | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | |
| K001831 | Needleless Transfer Device | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K001623 | Sculpture Flow | Jeneric/Pentron, Inc. | EBF | Class II | |
| K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 Channels) | Neuro Scan Labs | OLT | Class II | |
| K001255 | Cd Horizon Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K001234 | Bioinsulated Silicone Punctum Plug | Advanced Vision Science, Inc. | LZU | Unclassified | |
| K001231 | The Kalix Implant | New Deal, S.A. | HWC | Class II | |
| K001217 | Inside View | Monadnock Optics, Inc. | GCM | Class II | |
| K001194 | Sterichek Total Chlorine Reagent Strips | Environmental Test Systems, Inc. | MSY | Class II | |
| K000902 | Klinidrape Reinforced Surgical Gowns | Molnlycke Health Care | FYA | Class II | |
| K000837 | Puma Dental Chair and Unit | Castellini S.p.A. | EIA | Class I | |
| K994409 | Instant-View Opiates/morphine Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DPK | Class II | |
| K001902 | Bojrab Universal Long Imlant, Model Tbd | Gyrus Ent LLC | ETA | Class II | |
| K001812 | Pediatric Reference Data | Lunar Corp. | KGI | Class II | |
| K001625 | Pronova Nonabsorbable Suture, Usp | Ethicon, Inc | GAW | Class II | |
| K001356 | Ontrak Testcup Pro-5, Model 1986678 | Roche Diagnostics GmbH | DJC | Class II | |
| K001214 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | LPN | Class II | |
| K000124 | Sensation -Vacuum Assist Devices | Prosurg, Inc | LKY | Class II | |
| K994032 | Fluoro-Tex Cardiovascular Patch | Bridger Biomed, Inc. | DXZ | Class II | |
| K001912 | Im-9B Microinjectors | Narishige Co., Ltd. | MQJ | Class II | |
| K001911 | Im-9A Microinjectors | Narishige Co., Ltd. | MQJ | Class II | |
| K001910 | Im-9C Microinjectors | Narishige Co., Ltd. | MQJ | Class II | |
| K001822 | The V-Bag | Circulatory Technology, Inc. | DTN | Class II | |
| K001778 | Porocoat Prodigy Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K001707 | Diamedix Is-Toxoplasma Igm Capture Test System | Diamedix Corp. | LGD | Class II | |
| K001494 | Modification to Prompt L-Pop | Espe Dental AG | KLE | Class II | |
| K001371 | Cardeon Ascending Balloon Cannula (Abc) | Cardeon Corp. | DWF | Class II | |
| K001320 | Sulzer Orthopedics Inc. Natural-Hip System Ld Stem | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K001251 | Sniper, Model or-3872Xx Series | Nipro Medical Corporation | DQX | Class II | |
| K001228 | External Fixation Anchor Pin | Immedica, Inc. | JDW | Class II | |
| K001167 | Opi Band | Orthomerica Products, Inc. | MVA | Class II | |
| K001166 | Ultra V Therapeutic Ultrasound | Excel Tech., Ltd. | IMG | Class II | |
| K001156 | Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set | Gambro Renal Products | KDI | Class II | |
| K001143 | Release Nf Antibacterial Foley Catheter, Antibacterial Personal Catheter | Rochester Medical Corp. | MJC | Class II | |
| K001111 | Panoret, Model 1000A | CMT Medical Technologies, Ltd. | HKL | Class II | |
| K001063 | Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146f7, C146hf7, S146f7, S146hf7 | Baxter Healthcare Corporation | DYG | Class II | |
| K000062 | Cordis Trapease Permanent Vena Cava Filter and Introduction Kit | Cordis US Corp. | DTK | Class II | |
| K994266 | Fdtens 2010 | FUJI Dynamics Limited | GZJ | Class II |